Trial Outcomes & Findings for A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL) (NCT NCT01716806)
NCT ID: NCT01716806
Last Updated: 2024-06-11
Results Overview
Objective response rate (ORR) per investigator was defined as the percentage of subjects with complete response (CR) or partial response (PR) through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts A, B, and C the response was assessed using the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
131 participants
Primary outcome timeframe
Up to 81 months
Results posted on
2024-06-11
Participant Flow
Participant milestones
| Measure |
Part A
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
28
|
22
|
22
|
21
|
31
|
7
|
|
Overall Study
Received at Least One Dose of Study Drug
|
27
|
22
|
20
|
21
|
30
|
7
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
28
|
22
|
22
|
21
|
31
|
7
|
Reasons for withdrawal
| Measure |
Part A
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Overall Study
Patient withdrawal of consent
|
4
|
2
|
4
|
3
|
2
|
0
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
0
|
2
|
1
|
0
|
|
Overall Study
Death
|
13
|
9
|
12
|
4
|
10
|
5
|
|
Overall Study
Received treatment past data cutoff of up to 16 doses of BV. AEs collected until end of study.
|
0
|
0
|
0
|
0
|
1
|
1
|
|
Overall Study
PI decision
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Change in performance status
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Sponsor terminated enrollment into Part C
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Sponsor direction
|
7
|
8
|
5
|
12
|
16
|
1
|
Baseline Characteristics
A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
Baseline characteristics by cohort
| Measure |
Part A
n=27 Participants
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
n=22 Participants
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
n=20 Participants
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
n=21 Participants
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
n=30 Participants
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
n=7 Participants
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Total
n=127 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
12 Participants
n=115 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
29 Participants
n=21 Participants
|
6 Participants
n=10 Participants
|
115 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
53 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
74 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
11 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
25 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
116 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
26 Participants
n=21 Participants
|
7 Participants
n=10 Participants
|
117 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
3 Participants
n=115 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1
|
12 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
63 Participants
n=115 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 2
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
28 Participants
n=115 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 3
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
7 Participants
n=115 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 4
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 5
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Missing
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Up to 81 monthsPopulation: All subjects who received at least one dose of study drug
Objective response rate (ORR) per investigator was defined as the percentage of subjects with complete response (CR) or partial response (PR) through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts A, B, and C the response was assessed using the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
Outcome measures
| Measure |
Part A
n=27 Participants
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
n=22 Participants
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
n=20 Participants
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)
|
93 Percentage of participants
Interval 75.7 to 99.1
|
95 Percentage of participants
Interval 77.2 to 99.9
|
85 Percentage of participants
Interval 62.1 to 96.8
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 60 monthsPopulation: All subjects who received at least one dose of study drug
Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Part D, the response was assessed using the Lugano Classification Revised Staging System for nodal non-Hodgkin and cHL (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC).
Outcome measures
| Measure |
Part A
n=21 Participants
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D)
|
86 Percentage of participants
Interval 63.7 to 97.0
|
—
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Up to 31 monthsPopulation: All subjects who received at least one dose of study drug
Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts E and F, the response was assessed per blinded independent central review (BICR) using the modified Lugano criteria.
Outcome measures
| Measure |
Part A
n=30 Participants
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
n=7 Participants
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F)
|
60 Percentage of participants
Interval 40.6 to 77.3
|
43 Percentage of participants
Interval 9.9 to 81.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 122 monthsPopulation: All subjects who received at least one dose of study drug
A treatment-emergent AE (TEAE) is defined as a newly occurring or worsening AE after the first dose of any study drug component. Treatment-related AEs are defined as treatment-emergent AEs that are determined by the investigator to be related to the treatment on study. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.
Outcome measures
| Measure |
Part A
n=27 Participants
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
n=22 Participants
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
n=20 Participants
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
n=21 Participants
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
n=30 Participants
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
n=7 Participants
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Adverse Events
Treatment-related TEAE leading to treatment discontinuation
|
11 Participants
|
9 Participants
|
8 Participants
|
2 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
Treatment-related TE SAE
|
3 Participants
|
3 Participants
|
9 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
Any TEAE
|
27 Participants
|
22 Participants
|
20 Participants
|
21 Participants
|
30 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events
Treatment-related TEAE
|
25 Participants
|
22 Participants
|
19 Participants
|
18 Participants
|
24 Participants
|
6 Participants
|
|
Number of Participants With Adverse Events
Any grade 3 or higher TEAE
|
17 Participants
|
10 Participants
|
18 Participants
|
16 Participants
|
18 Participants
|
7 Participants
|
|
Number of Participants With Adverse Events
Treatment-related grade 3 or higher TEAE
|
13 Participants
|
9 Participants
|
16 Participants
|
12 Participants
|
8 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events
Any treatment-emergent (TE) serious adverse event (SAE)
|
5 Participants
|
4 Participants
|
13 Participants
|
4 Participants
|
14 Participants
|
4 Participants
|
|
Number of Participants With Adverse Events
TEAE leading to death
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events
Treatment-related TEAE leading to death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events
TEAE leading to treatment discontinuation
|
11 Participants
|
11 Participants
|
12 Participants
|
5 Participants
|
9 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: All subjects who received at least one dose of study drug
Laboratory values were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.
Outcome measures
| Measure |
Part A
n=27 Participants
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
n=22 Participants
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
n=20 Participants
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
n=21 Participants
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
n=30 Participants
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
n=7 Participants
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities
Potassium Low, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Hemoglobin High, Grade 1
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Hemoglobin High. Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Hemoglobin High. Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Hemoglobin Low, Grade 2
|
5 Participants
|
6 Participants
|
6 Participants
|
5 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Hemoglobin Low, Grade 3
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Hemoglobin Low, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Leukocytes Low, Grade 1
|
2 Participants
|
3 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Abnormalities
Leukocytes Low, Grade 2
|
3 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Leukocytes Low, Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lymphocytes High, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lymphocytes Low, Grade 4
|
0 Participants
|
0 Participants
|
9 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Neutrophils Low, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Neutrophils Low, Grade 2
|
3 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Neutrophils Low, Grade 4
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Platelets Low, Grade 2
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Platelets Low, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Platelets Low, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Alanine Aminotransferase High, Grade 1
|
8 Participants
|
9 Participants
|
6 Participants
|
16 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Alanine Aminotransferase High, Grade 2
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Alanine Aminotransferase High, Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Alanine Aminotransferase High, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Albumin Low, Grade 1
|
8 Participants
|
6 Participants
|
9 Participants
|
9 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities
Albumin Low, Grade 2
|
3 Participants
|
3 Participants
|
5 Participants
|
6 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Albumin Low, Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Alkaline Phosphatase High, Grade 1
|
10 Participants
|
10 Participants
|
5 Participants
|
4 Participants
|
12 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities
Alkaline Phosphatase High, Grade 2
|
3 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Alkaline Phosphatase High, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Amylase High, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Amylase High, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Amylase High, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Amylase High, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Aspartate Aminotransferase High, Grade 1
|
14 Participants
|
8 Participants
|
8 Participants
|
16 Participants
|
9 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Potassium Low, Grade 3
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Aspartate Aminotransferase High, Grade 2
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Aspartate Aminotransferase High, Grade 3
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Aspartate Aminotransferase High, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Calcium Corrected for Albumin High, Grade 1
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
6 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Calcium Corrected for Albumin High, Grade 2
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Calcium Corrected for Albumin High, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Calcium Corrected for Albumin High, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Calcium Corrected for Albumin Low, Grade 1
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities
Calcium Corrected for Albumin Low, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Calcium Corrected for Albumin Low, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Creatinine High, Grade 1
|
20 Participants
|
14 Participants
|
12 Participants
|
12 Participants
|
18 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities
Creatinine High, Grade 2
|
2 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Creatinine High, Grade 3
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Glomerular Filtration Rate, Estimated Low, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Glomerular Filtration Rate, Estimated Low, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
11 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities
Glomerular Filtration Rate, Estimated Low, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Glomerular Filtration Rate, Estimated Low, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Glucose High, Grade 1
|
15 Participants
|
13 Participants
|
12 Participants
|
12 Participants
|
11 Participants
|
3 Participants
|
|
Number of Participants With Laboratory Abnormalities
Glucose High, Grade 2
|
10 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
8 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities
Glucose High, Grade 3
|
2 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Glucose High, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Glucose Low, Grade 1
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Glucose Low, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Glucose Low, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Glucose Low, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lipase High, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lipase High, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lipase High, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lipase High, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Phosphate Low, Grade 1
|
9 Participants
|
8 Participants
|
2 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Phosphate Low, Grade 2
|
2 Participants
|
5 Participants
|
3 Participants
|
6 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Phosphate Low, Grade 3
|
2 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Phosphate Low, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Potassium High, Grade 1
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Potassium High, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Potassium High, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Potassium High, Grade 4
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Potassium Low, Grade 4
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Sodium High, Grade 1
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Sodium High, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Sodium High, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Sodium High, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Sodium Low, Grade 1
|
11 Participants
|
7 Participants
|
4 Participants
|
9 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Sodium Low, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Sodium Low, Grade 3
|
1 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Sodium Low, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Total Bilirubin High, Grade 1
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Total Bilirubin High, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Total Bilirubin High, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Total Bilirubin High, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Urate High, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Urate High, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Urate High, Grade 3
|
5 Participants
|
7 Participants
|
4 Participants
|
9 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Urate High, Grade 4
|
3 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Hemoglobin High. Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Hemoglobin Low, Grade 1
|
10 Participants
|
6 Participants
|
10 Participants
|
9 Participants
|
13 Participants
|
4 Participants
|
|
Number of Participants With Laboratory Abnormalities
Leukocytes Low, Grade 3
|
0 Participants
|
1 Participants
|
5 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lymphocytes High, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lymphocytes High, Grade 2
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lymphocytes High, Grade 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lymphocytes Low, Grade 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lymphocytes Low, Grade 2
|
4 Participants
|
7 Participants
|
2 Participants
|
6 Participants
|
7 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities
Lymphocytes Low, Grade 3
|
6 Participants
|
2 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities
Neutrophils Low, Grade 3
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities
Platelets Low, Grade 1
|
4 Participants
|
2 Participants
|
8 Participants
|
3 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants With Laboratory Abnormalities
Albumin Low, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Alkaline Phosphatase High, Grade 3
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Calcium Corrected for Albumin Low, Grade 2
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Creatinine High, Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Laboratory Abnormalities
Potassium Low, Grade 1
|
6 Participants
|
5 Participants
|
5 Participants
|
8 Participants
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to 81 monthsPopulation: All subjects who received at least one dose of study drug
Complete response rate is defined as the percentage of patients with CR
Outcome measures
| Measure |
Part A
n=27 Participants
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
n=22 Participants
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
n=20 Participants
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
n=21 Participants
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
n=30 Participants
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
n=7 Participants
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Complete Response Rate
|
70 Percentage of participants
Interval 49.8 to 86.2
|
64 Percentage of participants
Interval 40.7 to 82.8
|
75 Percentage of participants
Interval 50.9 to 91.3
|
67 Percentage of participants
Interval 43.0 to 85.4
|
30 Percentage of participants
Interval 14.7 to 49.4
|
43 Percentage of participants
Interval 9.9 to 81.6
|
SECONDARY outcome
Timeframe: Up to 81 monthsPopulation: All subjects with CR
Duration of CR per investigator was defined as the time from start of the first documentation of CR to the first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
Outcome measures
| Measure |
Part A
n=19 Participants
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
n=14 Participants
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
n=15 Participants
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
n=14 Participants
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
n=10 Participants
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
n=2 Participants
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Duration of Complete Response
|
7.4 Months
Interval 5.1 to
Follow-up duration too short relative to event accumulation to estimate upper limit.
|
NA Months
Interval 14.7 to
Follow-up duration too short relative to event accumulation to estimate median and upper limit.
|
NA Months
Interval 2.8 to
Follow-up duration too short relative to event accumulation to estimate median and upper limit.
|
NA Months
Interval 6.6 to
Follow-up duration too short relative to event accumulation to estimate median and upper limit.
|
NA Months
Interval 7.4 to
Follow-up duration too short relative to event accumulation to estimate median and upper limit.
|
NA Months
Follow-up duration too short relative to event accumulation to estimate median, upper limit, and lower limit.
|
SECONDARY outcome
Timeframe: Up to 81 monthsPopulation: All subjects with CR/PR
Duration of response per investigator was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (PD) based on radiographic evidence of progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
Outcome measures
| Measure |
Part A
n=25 Participants
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
n=21 Participants
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
n=17 Participants
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
n=18 Participants
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
n=18 Participants
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
n=3 Participants
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Duration of Objective Response
|
7.6 Months
Interval 5.1 to 67.7
|
46.0 Months
Interval 8.5 to
Follow-up duration too short relative to event accumulation to estimate upper limit.
|
NA Months
Interval 3.6 to
Follow-up duration too short relative to event accumulation to estimate median and upper limit.
|
NA Months
Interval 12.7 to
Follow-up duration too short relative to event accumulation to estimate median and upper limit.
|
7.4 Months
Interval 7.4 to
Follow-up duration too short relative to event accumulation to estimate upper limit.
|
NA Months
Interval 11.3 to
Follow-up duration too short relative to event accumulation to estimate median and upper limit.
|
SECONDARY outcome
Timeframe: Up to 83 monthsPopulation: All subjects who received at least one dose of study drug
Progression-free survival (PFS) per investigator was defined as the time from start of study treatment to first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
Outcome measures
| Measure |
Part A
n=27 Participants
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
n=22 Participants
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
n=20 Participants
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
n=21 Participants
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
n=30 Participants
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
n=7 Participants
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Progression-free Survival
|
8.6 Months
Interval 6.3 to 40.1
|
47.2 Months
Interval 10.8 to
Follow-up duration too short relative to event accumulation to estimate upper limit.
|
32.5 Months
Interval 4.0 to
Follow-up duration too short relative to event accumulation to estimate upper limit.
|
NA Months
Interval 9.4 to
Follow-up duration too short relative to event accumulation to estimate median and upper limit.
|
8.7 Months
Interval 5.1 to
Follow-up duration too short relative to event accumulation to estimate upper limit.
|
10.5 Months
Interval 0.5 to
Follow-up duration too short relative to event accumulation to estimate upper limit.
|
SECONDARY outcome
Timeframe: Up to 81 monthsPopulation: All subjects who received at least one dose of study drug
Disease control rate (DCR) per investigator was defined as the percentage of subjects with CR, PR, or SD, per investigator assessment of best clinical response per Cheson 2007. For Parts E and F, the assessment was per BICR.
Outcome measures
| Measure |
Part A
n=27 Participants
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
n=22 Participants
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
n=20 Participants
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
n=21 Participants
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
n=30 Participants
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
n=7 Participants
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Disease Control Rate
|
100 Percentage of participants
Interval 87.2 to 100.0
|
95 Percentage of participants
Interval 77.2 to 99.9
|
85 Percentage of participants
Interval 62.1 to 96.8
|
90 Percentage of participants
Interval 69.6 to 98.8
|
77 Percentage of participants
Interval 57.7 to 90.1
|
57 Percentage of participants
Interval 18.4 to 90.1
|
SECONDARY outcome
Timeframe: Up to 31 monthsPopulation: All subjects who received at least one dose of study drug
Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment.
Outcome measures
| Measure |
Part A
n=30 Participants
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
n=7 Participants
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
ORR According to Lugano Criteria Per BICR (Parts E and F)
|
67 Percentage of participants
Interval 47.2 to 82.7
|
43 Percentage of participants
Interval 9.9 to 81.6
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 42 weeksPopulation: Subjects with any B symptom at baseline.
B symptom resolution rate per investigator was defined as the percentage of subjects with lymphoma-related B symptoms at baseline who achieved resolution of all B symptoms at any time during the treatment period.
Outcome measures
| Measure |
Part A
n=5 Participants
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
n=6 Participants
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
n=7 Participants
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
n=6 Participants
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
n=9 Participants
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
n=2 Participants
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
B Symptom Resolution Rate
|
100 Percentage of participants
Interval 47.8 to 100.0
|
100 Percentage of participants
Interval 54.1 to 100.0
|
86 Percentage of participants
Interval 42.1 to 99.6
|
67 Percentage of participants
Interval 22.3 to 95.7
|
0 Percentage of participants
No participants achieved B symptom resolution
|
0 Percentage of participants
No participants achieved B symptom resolution
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: Subjects with a baseline and at least one post-baseline sample.
Outcome measures
| Measure |
Part A
n=26 Participants
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
n=22 Participants
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
n=17 Participants
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
n=18 Participants
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
n=26 Participants
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
n=6 Participants
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA)
Baseline Negative
|
23 Participants
|
20 Participants
|
16 Participants
|
17 Participants
|
24 Participants
|
6 Participants
|
|
Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA)
Baseline Negative - Negative post-baseline
|
14 Participants
|
12 Participants
|
5 Participants
|
12 Participants
|
17 Participants
|
6 Participants
|
|
Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA)
Baseline Negative - Positive post-baseline
|
9 Participants
|
8 Participants
|
11 Participants
|
5 Participants
|
7 Participants
|
0 Participants
|
|
Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA)
Baseline Positive - Negative post-baseline
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA)
Baseline Positive: Treatment-boosted post-baseline
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA)
Baseline Positive
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 30 monthsPopulation: Subject with baseline negative anti-drug antibody (ADA)
Outcome measures
| Measure |
Part A
n=17 Participants
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only)
Cycle 1 (Pre-dose nivolumab)
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only)
First Positive Cycle (pre-dose) - Cycle 2
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only)
First Positive Cycle (pre-dose) - Cycle 8
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
|
Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only)
Any positive post-baseline
|
5 Participants
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 44 monthsPopulation: All subjects who received at least one dose of study drug
Overall survival (OS) per investigator was defined as the time from date of enrollment to date of death due to any cause.
Outcome measures
| Measure |
Part A
n=30 Participants
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
n=7 Participants
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Overall Survival (Parts E and F Only)
|
31.8 Months
Interval 14.8 to
Follow-up duration too short relative to event accumulation to estimate upper limit.
|
12.6 Months
Interval 0.5 to
Follow-up duration too short relative to event accumulation to estimate upper limit.
|
—
|
—
|
—
|
—
|
Adverse Events
Part A
Serious events: 5 serious events
Other events: 27 other events
Deaths: 13 deaths
Part B
Serious events: 4 serious events
Other events: 22 other events
Deaths: 9 deaths
Part C
Serious events: 13 serious events
Other events: 20 other events
Deaths: 12 deaths
Part D
Serious events: 4 serious events
Other events: 21 other events
Deaths: 4 deaths
Part E
Serious events: 14 serious events
Other events: 27 other events
Deaths: 10 deaths
Part F
Serious events: 4 serious events
Other events: 7 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
Part A
n=27 participants at risk
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
n=22 participants at risk
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
n=20 participants at risk
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
n=21 participants at risk
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
n=30 participants at risk
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
n=7 participants at risk
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Disseminated intravascular coagulation
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial flutter
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Endocrine disorders
Inappropriate antidiuretic hormone secretion
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Erosive oesophagitis
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Gait disturbance
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
General physical health deterioration
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Sudden death
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Septic shock
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Anaesthetic complication
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Pelvic fracture
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypervolaemia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Aphasia
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hemiparesis
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Urinary incontinence
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumomediastinum
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Orthostatic hypotension
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Part A
n=27 participants at risk
Brentuximab vedotin (BV) monotherapy in adults age 60 and above with classical Hodgkin Lymphoma (cHL). BV (1.8 mg/kg) was administered as an intravenous (IV) infusion on Day 1 of each 21-day cycle.
|
Part B
n=22 participants at risk
BV in combination with dacarbazine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Dacarbazine (375 mg/m\^2) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part C
n=20 participants at risk
BV in combination with bendamustine as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Bendamustine (70 mg/m\^2) was administered as an IV infusion on Day 1 and Day 2 of each 21-day cycle.
|
Part D
n=21 participants at risk
BV in combination with nivolumab as frontline therapy in adults aged 60 and above with cHL. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle. Nivolumab (3 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part E
n=30 participants at risk
BV as frontline monotherapy in patients with cHL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
Part F
n=7 participants at risk
BV as frontline monotherapy in patients with CD30-expressing PTCL who were unsuitable or unfit for combination chemotherapy. BV (1.8 mg/kg) was administered as an IV infusion on Day 1 of each 21-day cycle.
|
|---|---|---|---|---|---|---|
|
General disorders
Oedema peripheral
|
25.9%
7/27 • Number of events 8 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
27.3%
6/22 • Number of events 7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
25.0%
5/20 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
13.3%
4/30 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
7.4%
2/27 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
18.5%
5/27 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
13.6%
3/22 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
13.3%
4/30 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
7.4%
2/27 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
13.6%
3/22 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
33.3%
7/21 • Number of events 11 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
44.4%
12/27 • Number of events 12 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
45.5%
10/22 • Number of events 10 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
50.0%
10/20 • Number of events 11 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
76.2%
16/21 • Number of events 22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
30.0%
9/30 • Number of events 11 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Gait disturbance
|
7.4%
2/27 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Oedema
|
11.1%
3/27 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.4%
2/27 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.4%
2/27 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
13.6%
3/22 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
25.0%
5/20 • Number of events 7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Eye disorders
Eye irritation
|
7.4%
2/27 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
13.6%
3/22 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
25.0%
5/20 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
3/30 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.4%
2/27 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
29.6%
8/27 • Number of events 9 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
45.5%
10/22 • Number of events 12 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
35.0%
7/20 • Number of events 7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
47.6%
10/21 • Number of events 11 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
16.7%
5/30 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
33.3%
9/27 • Number of events 13 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
27.3%
6/22 • Number of events 9 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
85.0%
17/20 • Number of events 21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
42.9%
9/21 • Number of events 10 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
23.3%
7/30 • Number of events 12 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
57.1%
4/7 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Frequent bowel movements
|
7.4%
2/27 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
11.1%
3/27 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
44.4%
12/27 • Number of events 12 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
40.9%
9/22 • Number of events 11 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
65.0%
13/20 • Number of events 16 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
38.1%
8/21 • Number of events 8 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
33.3%
10/30 • Number of events 12 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
42.9%
3/7 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Peripheral swelling
|
11.1%
3/27 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
7.4%
2/27 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
18.2%
4/22 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
35.0%
7/20 • Number of events 8 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
33.3%
7/21 • Number of events 11 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
COVID-19
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Candida infection
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Cellulitis
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Otitis media
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Pneumonia
|
7.4%
2/27 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Rash pustular
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Tooth infection
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
18.5%
5/27 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
13.6%
3/22 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
25.0%
5/20 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
3/27 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
22.7%
5/22 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
25.0%
5/20 • Number of events 11 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Foot fracture
|
7.4%
2/27 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
28.6%
6/21 • Number of events 7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Amylase increased
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
3.7%
1/27 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Lipase increased
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 9 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
22.2%
6/27 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
22.7%
5/22 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
25.0%
5/20 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
13.3%
4/30 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
42.9%
3/7 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
29.6%
8/27 • Number of events 8 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
22.7%
5/22 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
45.0%
9/20 • Number of events 9 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
33.3%
7/21 • Number of events 7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
26.7%
8/30 • Number of events 9 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Dehydration
|
11.1%
3/27 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
35.0%
7/20 • Number of events 8 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
11.1%
3/27 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
11.1%
3/27 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
25.0%
5/20 • Number of events 8 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.4%
2/27 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.8%
4/27 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
31.8%
7/22 • Number of events 8 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
33.3%
7/21 • Number of events 10 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
16.7%
5/30 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
3/30 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
14.8%
4/27 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
18.2%
4/22 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
13.6%
3/22 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
3/30 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 8 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
3/30 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dizziness
|
14.8%
4/27 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
18.2%
4/22 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
13.3%
4/30 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysgeusia
|
11.1%
3/27 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
22.7%
5/22 • Number of events 7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Hypoaesthesia
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Paraesthesia
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.5%
2/21 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral motor neuropathy
|
11.1%
3/27 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
13.6%
3/22 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
23.8%
5/21 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
77.8%
21/27 • Number of events 22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
77.3%
17/22 • Number of events 21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
40.0%
8/20 • Number of events 8 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
47.6%
10/21 • Number of events 16 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
46.7%
14/30 • Number of events 16 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
57.1%
4/7 • Number of events 8 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Syncope
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Taste disorder
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
7.4%
2/27 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
13.6%
3/22 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
3/30 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.5%
5/27 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
18.2%
4/22 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
30.0%
6/20 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.4%
2/27 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
22.7%
5/22 • Number of events 8 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
18.2%
4/22 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.7%
1/27 • Number of events 14 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
2/20 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
3.7%
1/27 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
18.5%
5/27 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
18.2%
4/22 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
25.0%
5/20 • Number of events 5 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
20.0%
6/30 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
18.2%
4/22 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
15.0%
3/20 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
19.0%
4/21 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.7%
2/30 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
3.7%
1/27 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
13.6%
3/22 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.0%
1/20 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.0%
3/30 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
22.2%
6/27 • Number of events 7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
27.3%
6/22 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
20.0%
6/30 • Number of events 10 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
28.6%
2/7 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.9%
7/27 • Number of events 10 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
22.7%
5/22 • Number of events 7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
20.0%
4/20 • Number of events 4 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
3/21 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.3%
1/30 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
11.1%
3/27 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
28.6%
6/21 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
20.0%
6/30 • Number of events 11 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Deep vein thrombosis
|
11.1%
3/27 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.1%
2/22 • Number of events 2 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 3 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/7 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
1/22 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/20 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/21 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
0.00%
0/27 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/22 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
25.0%
5/20 • Number of events 6 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.8%
1/21 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/30 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
1/7 • Number of events 1 • Non-serious Adverse Events, Serious Adverse Events, and All-Cause Mortality were followed for up to 122 months
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place