Trial Outcomes & Findings for Dose Escalation and Efficacy Study of mRNA-2416 for Intratumoral Injection Alone and in Combination With Durvalumab for Participants With Advanced Malignancies (NCT NCT03323398)
NCT ID: NCT03323398
Last Updated: 2024-07-31
Results Overview
DLTs: assessed by Investigator as unrelated to disease, disease progression, intercurrent illness, or concomitant medications; at least possibly related to study drug; and occurred within first 28 days of the study. DLTs in Arm A participants: Grade (Gr)3 adverse events (AEs) (except Gr3 thrombocytopenia lasting \<7 days/Gr3 neutropenia without fever or lasting \<7 days) and any Gr4/5 toxicity. DLTs (criteria assessed by Investigator) participants in Arm B: diarrhea/colitis; pneumonitis; hepatitis; rash; peripheral neuromotor syndromes; myocarditis; myositis/polymyositis; endocrinopathies involving thyroid, pituitary glands, or adrenal insufficiency; type I diabetes mellitus; nephritis; elevated amylase/lipase pancreatitis; all other immunemediated/nonimmunemediated AEs; infusion-related reactions; any Gr≥3 immune/nonimmune AE except vitiligo/alopecia; neutropenia Gr≥3 with fever/Gr4 lasting \>7 days; Gr≥3 thrombocytopenia and significant bleeding; Gr4 thrombocytopenia; and Gr4 anemia.
Recruitment status
TERMINATED
Study phase
PHASE1/PHASE2
Target enrollment
79 participants
Primary outcome timeframe
Days 1-28 (Cycle 1)
Results posted on
2024-07-31
Participant Flow
It was planned to include participants with lymphoma in the study, but none of the enrolled participants had lymphoma.
79 participants were enrolled into the study. 18 participants screen failed, and so 61 participants were randomized. Data are presented for the 61 randomized participants.
Participant milestones
| Measure |
Arm A, Dose Escalation: mRNA-2416 1.0 Milligrams (mg) Alone
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 1.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 2.0 mg Alone
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 2.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 4.0 mg Alone
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 4.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 8.0 mg Alone
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm B, Dose Escalation: mRNA-2416 4.0 mg and Durvalumab
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kilograms \[kg\] received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Confirmation: mRNA-2416 4.0 mg and Durvalumab
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab
Participants were administered mRNA-2416 through an intratumoral injection at 2.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 4.0 mg and Durvalumab
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
11
|
12
|
12
|
3
|
1
|
3
|
3
|
1
|
15
|
|
Overall Study
Received At Least 1 Dose of Study Drug
|
11
|
12
|
12
|
3
|
1
|
3
|
3
|
1
|
15
|
|
Overall Study
COMPLETED
|
2
|
1
|
2
|
1
|
0
|
0
|
1
|
0
|
7
|
|
Overall Study
NOT COMPLETED
|
9
|
11
|
10
|
2
|
1
|
3
|
2
|
1
|
8
|
Reasons for withdrawal
| Measure |
Arm A, Dose Escalation: mRNA-2416 1.0 Milligrams (mg) Alone
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 1.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 2.0 mg Alone
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 2.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 4.0 mg Alone
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 4.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 8.0 mg Alone
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm B, Dose Escalation: mRNA-2416 4.0 mg and Durvalumab
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kilograms \[kg\] received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Confirmation: mRNA-2416 4.0 mg and Durvalumab
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab
Participants were administered mRNA-2416 through an intratumoral injection at 2.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 4.0 mg and Durvalumab
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Overall Study
Other than Specified
|
0
|
1
|
2
|
0
|
0
|
0
|
1
|
0
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Death
|
4
|
6
|
2
|
2
|
1
|
2
|
0
|
0
|
6
|
|
Overall Study
Received Alternative Anticancer Therapy
|
2
|
1
|
2
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
2
|
1
|
3
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Participant was Put on Hospice
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Discontinued Following Discussion with Physician
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
Baseline characteristics by cohort
| Measure |
Arm A, Dose Escalation: mRNA-2416 1.0 mg Alone
n=11 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 1.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 2.0 mg Alone
n=12 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 2.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 4.0 mg Alone
n=12 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 4.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 8.0 mg Alone
n=3 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone
n=1 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm B, Dose Escalation: mRNA-2416 4.0 mg and Durvalumab
n=3 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kilograms \[kg\] received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Confirmation: mRNA-2416 4.0 mg and Durvalumab
n=3 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab
n=1 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 2.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 4.0 mg and Durvalumab
n=15 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Total
n=61 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
64.6 years
STANDARD_DEVIATION 7.55 • n=11 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
59.8 years
STANDARD_DEVIATION 17.40 • n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
64.4 years
STANDARD_DEVIATION 11.18 • n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
69.3 years
STANDARD_DEVIATION 5.69 • n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
66.0 years
STANDARD_DEVIATION 7.81 • n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
50.3 years
STANDARD_DEVIATION 23.59 • n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
64.1 years
STANDARD_DEVIATION 64.0 • n=15 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
63.1 years
STANDARD_DEVIATION 11.74 • n=59 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
|
Sex: Female, Male
Female
|
4 Participants
n=11 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
4 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
8 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
1 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
0 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
2 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
15 Participants
n=15 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
34 Participants
n=59 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
|
Sex: Female, Male
Male
|
7 Participants
n=11 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
8 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
4 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
2 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
3 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
1 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
0 Participants
n=15 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
25 Participants
n=59 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=11 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
1 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
3 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
0 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
0 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
0 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
0 Participants
n=15 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
4 Participants
n=59 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=11 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
11 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
9 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
3 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
3 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
3 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
15 Participants
n=15 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
55 Participants
n=59 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=11 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
0 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
0 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
0 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
0 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
0 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
0 Participants
n=15 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
0 Participants
n=59 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
|
Race/Ethnicity, Customized
Race · White
|
10 Participants
n=11 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
11 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
10 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
3 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
3 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
2 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
14 Participants
n=15 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
53 Participants
n=59 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
|
Race/Ethnicity, Customized
Race · Other
|
0 Participants
n=11 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
1 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
0 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
0 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
0 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
0 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
0 Participants
n=15 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
1 Participants
n=59 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
|
Race/Ethnicity, Customized
Race · Not Reported
|
1 Participants
n=11 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
0 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
2 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
0 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
0 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
0 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
1 Participants
n=15 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
4 Participants
n=59 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
|
Race/Ethnicity, Customized
Race · Black or African American
|
0 Participants
n=11 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
0 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
0 Participants
n=12 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
0 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
0 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
1 Participants
n=3 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
—
|
0 Participants
n=15 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
1 Participants
n=59 Participants • No baseline characteristics data is reported for Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone or Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab to maintain participant confidentiality.
|
PRIMARY outcome
Timeframe: Days 1-28 (Cycle 1)Population: The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received.
DLTs: assessed by Investigator as unrelated to disease, disease progression, intercurrent illness, or concomitant medications; at least possibly related to study drug; and occurred within first 28 days of the study. DLTs in Arm A participants: Grade (Gr)3 adverse events (AEs) (except Gr3 thrombocytopenia lasting \<7 days/Gr3 neutropenia without fever or lasting \<7 days) and any Gr4/5 toxicity. DLTs (criteria assessed by Investigator) participants in Arm B: diarrhea/colitis; pneumonitis; hepatitis; rash; peripheral neuromotor syndromes; myocarditis; myositis/polymyositis; endocrinopathies involving thyroid, pituitary glands, or adrenal insufficiency; type I diabetes mellitus; nephritis; elevated amylase/lipase pancreatitis; all other immunemediated/nonimmunemediated AEs; infusion-related reactions; any Gr≥3 immune/nonimmune AE except vitiligo/alopecia; neutropenia Gr≥3 with fever/Gr4 lasting \>7 days; Gr≥3 thrombocytopenia and significant bleeding; Gr4 thrombocytopenia; and Gr4 anemia.
Outcome measures
| Measure |
Arm A, Dose Escalation: mRNA-2416 1.0 mg Alone
n=11 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 1.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 2.0 mg Alone
n=12 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 2.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 4.0 mg Alone
n=12 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 4.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 8.0 mg Alone
n=3 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone
n=1 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm B, Dose Escalation: mRNA-2416 4.0 mg and Durvalumab
n=3 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kilograms \[kg\] received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Confirmation: mRNA-2416 4.0 mg and Durvalumab
n=3 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab
n=1 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 2.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 4.0 mg and DurvalumabEdit
n=15 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kilograms \[kg\] received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Experienced Dose Limiting Toxicities (DLTs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)Population: The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received.
An AE is any adverse experience in a participant administered a study drug, whether or not it is considered drug related, that occurred during study participation. This would include any side effect, injury, toxicity, sensitivity reaction, intercurrent illness, or sudden death. Conditions that started before study entry were reported as an AE if the frequency, intensity, or character of the condition worsened during the study. A TEAE was defined as any AE that newly appeared, increased in frequency, or worsened in severity following initiation of study drug. A serious AE (SAE) was defined as any AE that resulted in death, is life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in disability/permanent damage, was a congenital anomaly/birth defect, or was an important medical event. A summary of SAEs and all nonserious AEs ("Other"), regardless of causality, is located in the Reported "Adverse Events" section.
Outcome measures
| Measure |
Arm A, Dose Escalation: mRNA-2416 1.0 mg Alone
n=11 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 1.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 2.0 mg Alone
n=12 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 2.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 4.0 mg Alone
n=12 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 4.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 8.0 mg Alone
n=3 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone
n=1 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm B, Dose Escalation: mRNA-2416 4.0 mg and Durvalumab
n=3 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kilograms \[kg\] received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Confirmation: mRNA-2416 4.0 mg and Durvalumab
n=3 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab
n=1 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 2.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 4.0 mg and DurvalumabEdit
n=15 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kilograms \[kg\] received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With a Treatment-Emergent AEs (TEAE) or a Serious AE
TEAE
|
10 Participants
|
12 Participants
|
12 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
15 Participants
|
|
Number of Participants With a Treatment-Emergent AEs (TEAE) or a Serious AE
SAE
|
3 Participants
|
6 Participants
|
7 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
11 Participants
|
PRIMARY outcome
Timeframe: Day 1 through 6 months after the last dose of study treatment, or until disease progression, whichever occurred first (maximum exposure=26.3 weeks)Population: The Activity Evaluable Set included all enrolled participants who received any amount of study drug and had at least 1 tumor response evaluation. Participants were included in the dose cohort to which they were enrolled. One of the participants excluded from this analysis for the arm labeled "Arm B, Dose Confirmation: mRNA-2416 4.0 mg and Durvalumab" was excluded due to a diagnosis of cervical cancer.
ORR was defined as the percentage of participants in the Activity Evaluable Set with best overall response of Partial Response (PR) or better, where the denominator was the number of participants with solid tumor. Solid tumor response was assessed by Investigators based on RECIST version 1.1 (complete response \[CR\], PR, stable disease \[SD\], progressive disease \[PD\], or not evaluable), and based on Immune-related Response Criteria (irRC) (immune-related CR, immune-related PR, immune-related SD, immune-related PD, or not evaluable). The 95% confidence interval (CI) was based on the Clopper-Pearson exact test.
Outcome measures
| Measure |
Arm A, Dose Escalation: mRNA-2416 1.0 mg Alone
n=8 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 1.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 2.0 mg Alone
n=9 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 2.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 4.0 mg Alone
n=8 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 4.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 8.0 mg Alone
n=3 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone
n=1 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm B, Dose Escalation: mRNA-2416 4.0 mg and Durvalumab
n=2 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kilograms \[kg\] received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Confirmation: mRNA-2416 4.0 mg and Durvalumab
n=3 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab
n=1 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 2.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 4.0 mg and DurvalumabEdit
n=13 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kilograms \[kg\] received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) Based on Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
0.0 percentage of participants
Interval 0.0 to 33.6
|
0.0 percentage of participants
Interval 0.0 to 36.9
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
7.7 percentage of participants
Interval 0.2 to 36.0
|
SECONDARY outcome
Timeframe: Day 1 through 6 months after last dose of study treatment, or until disease progression, whichever occurred first (maximum exposure=26.3 weeks)Population: The Activity Evaluable Set included all enrolled participants who received any amount of study drug and had at least 1 tumor response evaluation. Participants were included in the dose cohort to which they were enrolled. Here, overall number of participants analyzed signifies those who were evaluable for this outcome measure. Since only 1 participant had a PR, the duration of response could not be calculated.
Duration of response was defined as the time from first response (PR or better, as assessed by Investigators based on RECIST version 1.1) to first occurrence of a disease progression. Participants who never achieved a response were excluded from this analysis. DOR (days) = date of event/censoring - date of first response + 1. Duration of response could only be calculated if more than 1 participant had a PR. Since only 1 participant had a PR, the duration of response could not be calculated.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Day 1 through 6 months after last dose of study treatment, or until disease progression, whichever occurred first (maximum exposure=26.3 weeks)Population: The Activity Evaluable Set included all enrolled participants who received any amount of study drug and had at least 1 tumor response evaluation. Participants were included in the dose cohort to which they were enrolled. One of the participants excluded from this analysis for the arm labeled "Arm B, Dose Confirmation: mRNA-2416 4.0 mg and Durvalumab" was excluded due to a diagnosis of cervical cancer.
Disease control rate (DCR) was defined as the percentage of participants in the Activity Evaluable Set with best overall response of PR or better, or SD ≥55 days (from the first dose date to the last SD assessment, and without PD between), where the denominator is the number of participants with solid tumor. Solid tumor response was assessed by investigators based on RECIST version 1.1 (CR, PR, SD, PD, or not evaluable), and based on irRC (immune-related CR, immune-related PR, immune-related SD, immune-related PD, or not evaluable). The 95% CI was based on the Clopper-Pearson exact test.
Outcome measures
| Measure |
Arm A, Dose Escalation: mRNA-2416 1.0 mg Alone
n=8 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 1.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 2.0 mg Alone
n=9 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 2.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 4.0 mg Alone
n=8 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 4.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 8.0 mg Alone
n=3 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone
n=1 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm B, Dose Escalation: mRNA-2416 4.0 mg and Durvalumab
n=2 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kilograms \[kg\] received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Confirmation: mRNA-2416 4.0 mg and Durvalumab
n=3 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab
n=1 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 2.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 4.0 mg and DurvalumabEdit
n=13 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kilograms \[kg\] received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Disease Control Rate in Participants With Ovarian Cancer (RECIST Version 1.1)
|
50.0 percentage of participants
Interval 15.7 to 84.3
|
33.3 percentage of participants
Interval 7.5 to 70.1
|
12.5 percentage of participants
Interval 0.3 to 52.7
|
33.3 percentage of participants
Interval 0.8 to 90.6
|
0.0 percentage of participants
Interval 0.0 to 97.5
|
0.0 percentage of participants
Interval 0.0 to 84.2
|
0.0 percentage of participants
Interval 0.0 to 70.8
|
100.0 percentage of participants
Interval 2.5 to 100.0
|
15.4 percentage of participants
Interval 1.9 to 45.4
|
SECONDARY outcome
Timeframe: Cycle (C) 1 Day (D) 1, C1D15, C2D1, C3D1, C3D15, C4D1, C5D1, C6D1, C6D15, End of Treatment (maximum exposure=26.3 weeks); Cycle =28 daysPopulation: The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received.
Data are presented for number of participants with anti-OX40L antibodies. OX40L is the protein translated by the drug product.
Outcome measures
| Measure |
Arm A, Dose Escalation: mRNA-2416 1.0 mg Alone
n=11 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 1.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 2.0 mg Alone
n=12 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 2.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 4.0 mg Alone
n=12 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 4.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 8.0 mg Alone
n=3 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone
n=1 Participants
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm B, Dose Escalation: mRNA-2416 4.0 mg and Durvalumab
n=3 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kilograms \[kg\] received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Confirmation: mRNA-2416 4.0 mg and Durvalumab
n=3 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab
n=1 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 2.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 4.0 mg and DurvalumabEdit
n=15 Participants
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kilograms \[kg\] received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Anti-OX40L Antibodies
C5D1
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-OX40L Antibodies
C6D15
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-OX40L Antibodies
C1D1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-OX40L Antibodies
C1D15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-OX40L Antibodies
C2D1
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-OX40L Antibodies
C3D1
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-OX40L Antibodies
C3D15
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-OX40L Antibodies
C4D1
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-OX40L Antibodies
C6D1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Anti-OX40L Antibodies
End of Treatment
|
4 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Arm A, Dose Escalation: mRNA-2416 1.0 mg Alone
Serious events: 3 serious events
Other events: 10 other events
Deaths: 4 deaths
Arm A, Dose Escalation: mRNA-2416 2.0 mg Alone
Serious events: 6 serious events
Other events: 12 other events
Deaths: 6 deaths
Arm A, Dose Escalation: mRNA-2416 4.0 mg Alone
Serious events: 7 serious events
Other events: 12 other events
Deaths: 3 deaths
Arm A, Dose Escalation: mRNA-2416 8.0 mg Alone
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Arm B, Dose Escalation: mRNA-2416 4.0 mg and Durvalumab
Serious events: 2 serious events
Other events: 3 other events
Deaths: 2 deaths
Arm B, Dose Confirmation: mRNA-2416 4.0 mg and Durvalumab
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Arm B, Dose Expansion: mRNA-2416 4.0 mg and Durvalumab
Serious events: 11 serious events
Other events: 15 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
Arm A, Dose Escalation: mRNA-2416 1.0 mg Alone
n=11 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 1.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 2.0 mg Alone
n=12 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 2.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 4.0 mg Alone
n=12 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 4.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 8.0 mg Alone
n=3 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone
n=1 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm B, Dose Escalation: mRNA-2416 4.0 mg and Durvalumab
n=3 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kilograms \[kg\] received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Confirmation: mRNA-2416 4.0 mg and Durvalumab
n=3 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab
n=1 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at 2.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 4.0 mg and Durvalumab
n=15 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Infections and infestations
Pneumonia
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Ovarian cancer
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
26.7%
4/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm progression
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Metabolism and nutrition disorders
Dehydration
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Vascular disorders
Hypertension
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Gastric volvulus
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Infections and infestations
Sepsis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Infections and infestations
Soft tissue infection
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Seizure
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Musculoskeletal and connective tissue disorders
Soft tissue necrosis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Asthenia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Face oedema
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Pyrexia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
Other adverse events
| Measure |
Arm A, Dose Escalation: mRNA-2416 1.0 mg Alone
n=11 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 1.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 2.0 mg Alone
n=12 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 2.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 4.0 mg Alone
n=12 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 4.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Escalation: mRNA-2416 8.0 mg Alone
n=3 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm A, Dose Confirmation: mRNA-2416 8.0 mg Alone
n=1 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at a dose of 8.0 mg on Days 1 and 15 for six 28-day cycles.
|
Arm B, Dose Escalation: mRNA-2416 4.0 mg and Durvalumab
n=3 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kilograms \[kg\] received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Confirmation: mRNA-2416 4.0 mg and Durvalumab
n=3 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 2.0 mg and Durvalumab
n=1 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at 2.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
Arm B, Dose Expansion: mRNA-2416 4.0 mg and Durvalumab
n=15 participants at risk
Participants were administered mRNA-2416 through an intratumoral injection at 4.0 mg on Days 1 and 15 of Cycle 1 and on Day 1 of Cycles 2 through 6 and durvalumab through an intravenous infusion at a fixed dose (1500 mg, except for participants whose weight fell to ≤30 kg received a weight-based dose at 20 mg/kg) on Day 1 of Cycles 1 through 6. The duration of each cycle was 28 days.
|
|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
5/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Infections and infestations
Pneumonia
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Infections and infestations
Skin infection
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Infections and infestations
Injection site infection
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Infections and infestations
Oesophageal candidiasis
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Infections and infestations
Sepsis
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Infections and infestations
Tooth infection
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Infections and infestations
Wound infection
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm swelling
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Salivary gland cancer
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour exudation
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Blood and lymphatic system disorders
Anaemia
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
25.0%
3/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
53.3%
8/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Endocrine disorders
Hypercalcaemia of malignancy
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Endocrine disorders
Hyperthyroidism
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Endocrine disorders
Hypothyroidism
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
66.7%
2/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
53.3%
8/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
66.7%
2/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
40.0%
6/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
40.0%
6/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
40.0%
6/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
26.7%
4/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
26.7%
4/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Psychiatric disorders
Anxiety
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Psychiatric disorders
Confusional state
|
27.3%
3/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Psychiatric disorders
Depression
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Headache
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
25.0%
3/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
40.0%
6/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Dizziness
|
27.3%
3/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
20.0%
3/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Aphasia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Depressed level of consciousness
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Somnolence
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Transient ischaemic attack
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Tremor
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Eye disorders
Visual impairment
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
66.7%
2/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Cardiac disorders
Sinus tachycardia
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Cardiac disorders
Atrial fibrillation
|
18.2%
2/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Cardiac disorders
Palpitations
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Vascular disorders
Hypotension
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
66.7%
2/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
26.7%
4/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Vascular disorders
Flushing
|
18.2%
2/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
25.0%
3/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
4/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
66.7%
2/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
20.0%
3/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Vascular disorders
Hot flush
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Vascular disorders
Essential hypertension
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Vascular disorders
Lymphoedema
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
25.0%
3/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
26.7%
4/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Reproductive system and breast disorders
Pelvic pain
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
2/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
20.0%
3/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
18.2%
2/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Nausea
|
36.4%
4/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
25.0%
3/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
4/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
66.7%
2/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
73.3%
11/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Diarrhoea
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
3/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
40.0%
6/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Abdominal pain
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
25.0%
3/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
46.7%
7/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Vomiting
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
41.7%
5/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
46.7%
7/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
26.7%
4/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Abdominal distension
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
20.0%
3/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Dry mouth
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
20.0%
3/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Dysphagia
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Tongue pigmentation
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Renal and urinary disorders
Hyperhidrosis
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
27.3%
3/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative generalised
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
25.0%
3/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
66.7%
2/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
5/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
4/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Renal and urinary disorders
Acute kidney injury
|
18.2%
2/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Renal and urinary disorders
Bladder spasm
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Renal and urinary disorders
Urinary tract pain
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Fatigue
|
36.4%
4/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
25.0%
3/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
50.0%
6/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
66.7%
2/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
80.0%
12/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Pyrexia
|
27.3%
3/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
25.0%
3/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
25.0%
3/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
66.7%
2/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
53.3%
8/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Injection site pain
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
41.7%
5/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
41.7%
5/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
53.3%
8/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Oedema peripheral
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
25.0%
3/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
26.7%
4/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Influenza like illness
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
20.0%
3/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Asthenia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Injection site erythema
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
4/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
66.7%
2/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Injection site rash
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Chest discomfort
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Face oedema
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Injection site discomfort
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Injection site pruritus
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Injection site swelling
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Malaise
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Swelling
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Catheter site bruise
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Cyst
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Facial pain
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Gait disturbance
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Injection site irritation
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Injection site oedema
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Injection site reaction
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Localised oedema
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Peripheral swelling
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
66.7%
2/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
5/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Lymphocyte count decreased
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
20.0%
3/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
66.7%
2/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
20.0%
3/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Amylase increased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
20.0%
3/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
20.0%
3/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Lipase increased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
20.0%
3/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Neutrophil count increased
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Injury, poisoning and procedural complications
Anastomotic ulcer
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Injury, poisoning and procedural complications
Breast injury
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
8.3%
1/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Chills
|
9.1%
1/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
16.7%
2/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
4/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
5/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to bone
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Action tremor
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Facial spasm
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Nerve compression
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Eye disorders
Dry eye
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Eye disorders
Vision blurred
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Vascular disorders
Hypertension
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchostenosis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
26.7%
4/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Dental discomfort
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
26.7%
4/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
20.0%
3/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Musculoskeletal and connective tissue disorders
Sacral pain
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Renal and urinary disorders
Bladder irritation
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
20.0%
3/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Axillary pain
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Generalised oedema
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Catheter site erythema
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Early satiety
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Injection site bruising
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Injection site mass
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Injection site vesicles
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Oedema
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
General disorders
Thirst
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
26.7%
4/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Platelet count decreased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
20.0%
3/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Weight decreased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Weight increased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
White blood cell count increased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
13.3%
2/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Antiphospholipid antibodies positive
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
100.0%
1/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Blood fibrinogen increased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Blood lactic acid increased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Investigations
Urine output decreased
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Injury, poisoning and procedural complications
Cystitis radiation
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Injury, poisoning and procedural complications
Fractured sacrum
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Injury, poisoning and procedural complications
Nerve root injury sacral
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
6.7%
1/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/11 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/12 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
33.3%
1/3 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/1 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
0.00%
0/15 • Day 1 up to 90 days after the last dose of study treatment (maximum exposure=26.3 weeks)
The Safety Set included all enrolled participants who received any amount of study drug. Participants were included in the dose cohort corresponding to the dose level they actually received. The data reported for "All-Cause Mortality" included the participants who were discontinued due to "Death" and the participant who was discontinued due to "Intent to go to a Hospice" who subsequently died.
|
Additional Information
Moderna Clinical Trials Support Center
ModernaTX, Inc.
Phone: 1-877-777-7187
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER