Trial Outcomes & Findings for Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma (NCT NCT03646123)
NCT ID: NCT03646123
Last Updated: 2025-08-28
Results Overview
The FN rate is defined as the number of participants who experience treatment-emergent FN.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
255 participants
Primary outcome timeframe
7.5 months
Results posted on
2025-08-28
Participant Flow
In this study participant's treatment was completed before primary completion date (PCD), and no treatment was administered after PCD, participants were followed up.
Participant milestones
| Measure |
Part A
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part B
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage II bulky mediastinal disease and Stage III or IV cHL.
|
Part C
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|---|
|
Overall Study
STARTED
|
41
|
58
|
156
|
|
Overall Study
Treated
|
40
|
57
|
154
|
|
Overall Study
COMPLETED
|
31
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
10
|
58
|
155
|
Reasons for withdrawal
| Measure |
Part A
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part B
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage II bulky mediastinal disease and Stage III or IV cHL.
|
Part C
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
3
|
|
Overall Study
Study termination by sponsor
|
0
|
45
|
139
|
|
Overall Study
Lost to Follow-up
|
4
|
10
|
10
|
|
Overall Study
Death
|
2
|
1
|
1
|
|
Overall Study
Other
|
2
|
0
|
2
|
Baseline Characteristics
Clinical Trial of Brentuximab Vedotin in Classical Hodgkin Lymphoma
Baseline characteristics by cohort
| Measure |
Part A
n=41 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part B
n=58 Participants
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage II bulky mediastinal disease and Stage III or IV cHL.
|
Part C
n=156 Participants
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
Total
n=255 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
28 years
n=5 Participants
|
35 years
n=7 Participants
|
31 years
n=5 Participants
|
31 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
86 Participants
n=5 Participants
|
129 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
126 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
36 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
34 Participants
n=5 Participants
|
46 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
207 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
31 Participants
n=5 Participants
|
50 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
212 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 0
|
27 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
124 Participants
n=5 Participants
|
185 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 1
|
13 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
64 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Grade 2
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
Missing
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 7.5 monthsPopulation: For Part A, the full analysis set included all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen).
The FN rate is defined as the number of participants who experience treatment-emergent FN.
Outcome measures
| Measure |
Part A
n=40 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Febrile Neutropenia (FN) Rate (Part A)
Grade 3 or higher treatment-related treatment-emergent FN
|
5 Participants
|
—
|
|
Febrile Neutropenia (FN) Rate (Part A)
Any treatment-emergent FN
|
5 Participants
|
—
|
|
Febrile Neutropenia (FN) Rate (Part A)
Treatment-related treatment-emergent FN
|
5 Participants
|
—
|
|
Febrile Neutropenia (FN) Rate (Part A)
Grade 3 or higher treatment-emergent FN
|
5 Participants
|
—
|
PRIMARY outcome
Timeframe: 7.8 monthsPopulation: For Parts B and C, the full analysis set included all participants who enrolled and received any amount of the combination therapy in the study.
CR rate at EOT is defined as the percentage of participants with CR at EOT, according to the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Cheson 2016), in participants with previously untreated cHL.
Outcome measures
| Measure |
Part A
n=57 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
n=154 Participants
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Complete Response (CR) Rate at EOT (Parts B and C)
|
88 Percentage of participants
Interval 76.3 to 94.9
|
92 Percentage of participants
Interval 86.0 to 95.4
|
SECONDARY outcome
Timeframe: Approximately up to 7.5 monthsPopulation: For Part A, the full analysis set included all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen).
An adverse event (AE) was any untoward medical occurrence in a clinical investigational participant administered a medicinal product and which did not necessarily have a causal relationship with the treatment. Participants with peripheral neuropathy (PN) adverse events were summarized under AECI.
Outcome measures
| Measure |
Part A
n=40 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Number of Participants With Adverse Events of Clinical Interest (AECI) (Part A)
|
32 Participants
|
—
|
SECONDARY outcome
Timeframe: 10.2 monthsPopulation: For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen).
The primary refractory disease rate is defined as the percentage of participants with less than complete response or relapse within 3 months of EOT, according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas
Outcome measures
| Measure |
Part A
n=40 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Primary Refractory Disease Rate (Part A)
|
10 percentage of participants
Interval 2.8 to 23.7
|
—
|
SECONDARY outcome
Timeframe: 7.2 monthsPopulation: For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen).
The complete response rate is defined as the percentage of participants with CR at EOT according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Cheson 2014).
Outcome measures
| Measure |
Part A
n=40 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Complete Response Rate (Part A)
|
80 percentage of participants
Interval 64.4 to 90.9
|
—
|
SECONDARY outcome
Timeframe: 24 monthsPopulation: For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen).
The physician-reported PFS rate at 2 years is estimated based on Kaplan-Meier methodology. The determination of antitumor activity will be based on response assessments made according to the Lugano Classification Revised Staging System for nodal non-Hodgkin and Hodgkin lymphomas (Cheson 2014).
Outcome measures
| Measure |
Part A
n=40 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Physician-reported Progression Free Survival (PFS) (Part A)
|
89.23 percentage of participants
Interval 73.76 to 95.82
|
—
|
SECONDARY outcome
Timeframe: 33.8 monthsPopulation: For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen).
Number of participants with subsequent anticancer therapy have been reported in this outcome measure.
Outcome measures
| Measure |
Part A
n=40 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Number of Participants With Subsequent Anticancer Therapy Utilization (Part A)
Participants with any subsequent therapy
|
6 Participants
|
—
|
|
Number of Participants With Subsequent Anticancer Therapy Utilization (Part A)
Consolidative radiotherapy: Radiotherapy
|
3 Participants
|
—
|
|
Number of Participants With Subsequent Anticancer Therapy Utilization (Part A)
Consolidative radiotherapy: Proton radiation
|
1 Participants
|
—
|
|
Number of Participants With Subsequent Anticancer Therapy Utilization (Part A)
Immunotherapy: Nivolumab
|
1 Participants
|
—
|
|
Number of Participants With Subsequent Anticancer Therapy Utilization (Part A)
Maintenance: Nivolumab
|
1 Participants
|
—
|
|
Number of Participants With Subsequent Anticancer Therapy Utilization (Part A)
Maintenance radiotherapy: Radiation therapy
|
1 Participants
|
—
|
|
Number of Participants With Subsequent Anticancer Therapy Utilization (Part A)
Systemic therapy for progressive disease: Bendamustine monotherapy
|
1 Participants
|
—
|
|
Number of Participants With Subsequent Anticancer Therapy Utilization (Part A)
Systemic therapy for relapsed disease: Nivolumab
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 6.5 monthsPopulation: For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen).
Outcome measures
| Measure |
Part A
n=40 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Actual Dose Intensity: Brentuximab Vedotin (Part A)
|
0.5 mg/kg/week
Standard Deviation 0.1
|
—
|
SECONDARY outcome
Timeframe: 6.5 monthsPopulation: For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen).
Outcome measures
| Measure |
Part A
n=40 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Actual Dose Intensity: Doxorubicin, Vinblastine, Dacarbazine (Part A)
Doxorubicin
|
11.8 mg/m2/week
Standard Deviation 1.0
|
—
|
|
Actual Dose Intensity: Doxorubicin, Vinblastine, Dacarbazine (Part A)
Vinblastine
|
2.7 mg/m2/week
Standard Deviation 0.4
|
—
|
|
Actual Dose Intensity: Doxorubicin, Vinblastine, Dacarbazine (Part A)
Dacarbazine
|
176.3 mg/m2/week
Standard Deviation 15.2
|
—
|
SECONDARY outcome
Timeframe: 6.5 monthsPopulation: For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen).
Outcome measures
| Measure |
Part A
n=40 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Relative Dose Intensity (Part A)
Brentuximab vedotin
|
91.0 percentage of intended dose
Standard Deviation 10.8
|
—
|
|
Relative Dose Intensity (Part A)
Doxorubicin
|
94.2 percentage of intended dose
Standard Deviation 8.2
|
—
|
|
Relative Dose Intensity (Part A)
Vinblastine
|
89.0 percentage of intended dose
Standard Deviation 13.6
|
—
|
|
Relative Dose Intensity (Part A)
Dacarbazine
|
94.0 percentage of intended dose
Standard Deviation 8.1
|
—
|
SECONDARY outcome
Timeframe: 6.5 monthsPopulation: For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen).
Outcome measures
| Measure |
Part A
n=40 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Rate of Dose Reduction and Delays: Brentuximab Vedotin (Part A)
Participants with any dose modification
|
29 Participants
|
—
|
|
Rate of Dose Reduction and Delays: Brentuximab Vedotin (Part A)
Participants with any dose delay
|
22 Participants
|
—
|
|
Rate of Dose Reduction and Delays: Brentuximab Vedotin (Part A)
Participants with any dose delay due to AE
|
15 Participants
|
—
|
|
Rate of Dose Reduction and Delays: Brentuximab Vedotin (Part A)
Participants with any dose delay due to other reason
|
14 Participants
|
—
|
|
Rate of Dose Reduction and Delays: Brentuximab Vedotin (Part A)
Participants with any dose reduction due to AE
|
14 Participants
|
—
|
SECONDARY outcome
Timeframe: 6.5 monthsPopulation: For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen).
Outcome measures
| Measure |
Part A
n=40 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Rate of Dose Reduction and Delays: Doxorubicin (Part A)
Participants with any dose delay due to AE
|
15 Participants
|
—
|
|
Rate of Dose Reduction and Delays: Doxorubicin (Part A)
Participants with any dose modification
|
25 Participants
|
—
|
|
Rate of Dose Reduction and Delays: Doxorubicin (Part A)
Participants with any dose delay
|
23 Participants
|
—
|
|
Rate of Dose Reduction and Delays: Doxorubicin (Part A)
Participants with any dose delay due to other reason
|
15 Participants
|
—
|
|
Rate of Dose Reduction and Delays: Doxorubicin (Part A)
Participants with any dose reduction due to AE
|
7 Participants
|
—
|
SECONDARY outcome
Timeframe: 6.5 monthsPopulation: For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen).
Outcome measures
| Measure |
Part A
n=40 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Rate of Dose Reduction and Delays: Vinblastine (Part A)
Participants with any dose modification
|
27 Participants
|
—
|
|
Rate of Dose Reduction and Delays: Vinblastine (Part A)
Participants with any dose delay
|
22 Participants
|
—
|
|
Rate of Dose Reduction and Delays: Vinblastine (Part A)
Participants with any dose delay due to AE
|
15 Participants
|
—
|
|
Rate of Dose Reduction and Delays: Vinblastine (Part A)
Participants with any dose delay due to other reason
|
14 Participants
|
—
|
|
Rate of Dose Reduction and Delays: Vinblastine (Part A)
Participants with any dose reduction due to AE
|
12 Participants
|
—
|
SECONDARY outcome
Timeframe: 6.5 monthsPopulation: For Part A, the full analysis set includes all participants who received at least 1 dose of A+AVD (any of the study drugs in the regimen).
Outcome measures
| Measure |
Part A
n=40 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Rate of Dose Reduction and Delays: Dacarbazine (Part A)
Participants with any dose modification
|
25 Participants
|
—
|
|
Rate of Dose Reduction and Delays: Dacarbazine (Part A)
Participants with any dose delay
|
22 Participants
|
—
|
|
Rate of Dose Reduction and Delays: Dacarbazine (Part A)
Participants with any dose delay due to AE
|
15 Participants
|
—
|
|
Rate of Dose Reduction and Delays: Dacarbazine (Part A)
Participants with any dose delay due to other reason
|
14 Participants
|
—
|
|
Rate of Dose Reduction and Delays: Dacarbazine (Part A)
Participants with any dose reduction due to AE
|
6 Participants
|
—
|
SECONDARY outcome
Timeframe: 8.9 monthsPopulation: For Parts B and C, the full analysis set includes all participants who enrolled and received any amount of the combination therapy in the study.
Outcome measures
| Measure |
Part A
n=57 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
n=154 Participants
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Incidence of Adverse Events (Parts B and C)
Treatment-related TEAE
|
56 Participants
|
149 Participants
|
|
Incidence of Adverse Events (Parts B and C)
Participants who discontinued treatment due to treatment-related TEAE
|
4 Participants
|
4 Participants
|
|
Incidence of Adverse Events (Parts B and C)
TEAE leading to death
|
0 Participants
|
0 Participants
|
|
Incidence of Adverse Events (Parts B and C)
Any treatment-emergent adverse event (TEAE)
|
57 Participants
|
153 Participants
|
|
Incidence of Adverse Events (Parts B and C)
Grade 3 or higher TEAE
|
29 Participants
|
67 Participants
|
|
Incidence of Adverse Events (Parts B and C)
Grade 3 or higher treatment-related TEAE
|
19 Participants
|
52 Participants
|
|
Incidence of Adverse Events (Parts B and C)
Any treatment-emergent serious adverse event (SAE)
|
15 Participants
|
29 Participants
|
|
Incidence of Adverse Events (Parts B and C)
Treatment-related treatment-emergent SAE
|
8 Participants
|
19 Participants
|
|
Incidence of Adverse Events (Parts B and C)
Participants who discontinued treatment due to TEAE
|
4 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 8.9 monthsPopulation: For Parts B and C, the full analysis set included all participants who enrolled and received any amount of the combination therapy in the study.
Laboratory values were graded according to the National Cancer Institute's (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). As per NCI CTCAE version 4.03 grading, Grade 1 indicated mild or asymptomatic laboratory abnormalities, Grade 2 indicated moderate laboratory abnormalities, and Grade 3 indicated severe and 4 indicated life-threatening laboratory abnormalities.
Outcome measures
| Measure |
Part A
n=57 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
n=154 Participants
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Leukocytes high, Grade 1
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Hemoglobin high, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Leukocytes high, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Leukocytes low, Grade 2
|
12 Participants
|
24 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Hemoglobin low, Grade 1
|
37 Participants
|
96 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Hemoglobin low, Grade 2
|
10 Participants
|
6 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Hemoglobin high, Grade 2
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Lymphocytes high, Grade 1
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Lymphocytes low, Grade 1
|
11 Participants
|
31 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Lymphocytes low, Grade 3
|
7 Participants
|
9 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Neutrophils low, Grade 1
|
4 Participants
|
12 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Neutrophils low, Grade 2
|
14 Participants
|
38 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Alanine aminotransferase high, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Calcium corrected for albumin high, Grade 2
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Calcium corrected for albumin high, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Calcium corrected for albumin low, Grade 1
|
7 Participants
|
5 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Creatinine high, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Estimated glomerular filtration rate low, Grade 1
|
1 Participants
|
8 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Glucose high, Grade 2
|
5 Participants
|
9 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Glucose high, Grade 3
|
1 Participants
|
13 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Glucose low, Grade 2
|
1 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Glucose low, Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Lipase high, Grade 3
|
5 Participants
|
6 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Potassium high, Grade 2
|
0 Participants
|
1 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Albumin low, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Alkaline phosphatase high, Grade 1
|
30 Participants
|
51 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Alkaline phosphatase high, Grade 2
|
2 Participants
|
1 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Alkaline phosphatase high, Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Alkaline phosphatase high, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Amylase high, Grade 1
|
3 Participants
|
15 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Amylase high, Grade 2
|
2 Participants
|
6 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Amylase high, Grade 3
|
0 Participants
|
6 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Amylase high, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Aspartate aminotransferase high, Grade 1
|
27 Participants
|
75 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Aspartate aminotransferase high, Grade 2
|
1 Participants
|
7 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Aspartate aminotransferase high, Grade 3
|
2 Participants
|
1 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Aspartate aminotransferase high, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Calcium corrected for albumin high, Grade 1
|
12 Participants
|
18 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Calcium corrected for albumin high, Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Calcium corrected for albumin low, Grade 2
|
0 Participants
|
1 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Calcium corrected for albumin low, Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Calcium corrected for albumin low, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Ionized calcium high, Grade 1
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Ionized calcium high, Grade 2
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Ionized calcium high, Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Ionized calcium high, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Ionized calcium low, Grade 1
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Ionized calcium low, Grade 2
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Ionized calcium low, Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Ionized calcium low, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Creatinine high, Grade 1
|
47 Participants
|
127 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Creatinine high, Grade 2
|
5 Participants
|
11 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Creatinine high, Grade 3
|
1 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Estimated glomerular filtration rate low, Grade 2
|
4 Participants
|
10 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Estimated glomerular filtration rate low, Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Estimated glomerular filtration rate low, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Glucose high, Grade 1
|
45 Participants
|
69 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Glucose high, Grade 4
|
1 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Glucose low, Grade 1
|
12 Participants
|
18 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Glucose low, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Lipase high, Grade 1
|
9 Participants
|
13 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Lipase high, Grade 2
|
1 Participants
|
6 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Lipase high, Grade 4
|
0 Participants
|
3 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Phosphate low, Grade 1
|
1 Participants
|
3 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Phosphate low, Grade 2
|
7 Participants
|
9 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Phosphate low, Grade 3
|
2 Participants
|
4 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Phosphate low, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Potassium high, Grade 1
|
3 Participants
|
7 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Potassium high, Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Potassium high, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Potassium low, Grade 1
|
9 Participants
|
19 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Potassium low, Grade 2
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Potassium low, Grade 3
|
2 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Potassium low, Grade 4
|
1 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Sodium high, Grade 1
|
2 Participants
|
3 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Sodium high, Grade 2
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Sodium high, Grade 3
|
0 Participants
|
1 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Sodium high, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Sodium low, Grade 1
|
11 Participants
|
25 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Sodium low, Grade 2
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Sodium low, Grade 3
|
2 Participants
|
2 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Sodium low, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Total bilirubin high, Grade 1
|
1 Participants
|
8 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Total bilirubin high, Grade 2
|
2 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Total bilirubin high, Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Total bilirubin high, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Urate high, Grade 1
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Urate high, Grade 2
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Urate high, Grade 3
|
10 Participants
|
28 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Urate high, Grade 4
|
0 Participants
|
1 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Hemoglobin high, Grade 1
|
0 Participants
|
4 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Hemoglobin high, Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Hemoglobin low, Grade 3
|
1 Participants
|
1 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Hemoglobin low, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Leukocytes high, Grade 2
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Leukocytes high, Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Leukocytes low, Grade 1
|
19 Participants
|
41 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Leukocytes low, Grade 3
|
0 Participants
|
2 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Leukocytes low, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Lymphocytes high, Grade 2
|
1 Participants
|
3 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Lymphocytes high, Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Lymphocytes high, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Lymphocytes low, Grade 2
|
17 Participants
|
22 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Lymphocytes low, Grade 4
|
1 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Neutrophils low, Grade 3
|
4 Participants
|
11 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Neutrophils low, Grade 4
|
2 Participants
|
3 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Platelets low, Grade 1
|
6 Participants
|
22 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Platelets low, Grade 2
|
1 Participants
|
1 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Platelets low, Grade 3
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Platelets low, Grade 4
|
0 Participants
|
0 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Alanine aminotransferase high, Grade 1
|
26 Participants
|
71 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Alanine aminotransferase high, Grade 2
|
3 Participants
|
16 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Alanine aminotransferase high, Grade 3
|
4 Participants
|
10 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Albumin low, Grade 1
|
11 Participants
|
22 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Albumin low, Grade 2
|
3 Participants
|
6 Participants
|
|
Incidence of Laboratory Abnormalities (Parts B and C)
Albumin low, Grade 3
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 7.8 monthsPopulation: For Parts B and C, the full analysis set included all participants who were enrolled and received any amount of the combination therapy in the study.
ORR is defined as the percentage of participants with CR or partial response (PR) at EOT according to the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016) in participants with previously untreated cHL.
Outcome measures
| Measure |
Part A
n=57 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
n=154 Participants
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Overall Response Rate (ORR) at EOT (Parts B and C)
|
93 Percentage of participants
Interval 83.0 to 98.1
|
96 Percentage of participants
Interval 91.7 to 98.6
|
SECONDARY outcome
Timeframe: Up to 51.1 monthsPopulation: For Parts B and C, the full analysis set includes all participants who were enrolled and received any amount of the combination therapy in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
DOR was defined as the time from the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression per the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016) or death, whichever came first. Duration of response was only calculated for the subgroup of participants achieving a CR or PR. Participants without progression or death were censored on the date of the last radiological assessment of measured lesions. Kaplan-Meier method was used.
Outcome measures
| Measure |
Part A
n=56 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
n=154 Participants
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Duration of Response (DOR) at End of Study (Parts B and C)
|
NA Months
Median and 95% CI were not estimable due to insufficient number of participants with event.
|
NA Months
Median and 95% CI were not estimable due to insufficient number of participants with event.
|
SECONDARY outcome
Timeframe: Up to 51.1 monthsPopulation: For Parts B and C, the full analysis set includes all participants who were enrolled and received any amount of the combination therapy in the study. Here, "Overall Number of Participants Analyzed" signifies participants evaluable for this outcome measure.
DOCR was defined as the time from start of the first documentation of CR to the first documentation of tumor progression (per the Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016) or death, whichever came first. DOCR was calculated for the subgroup of participants achieving CR. Participants without progression or death were censored on the date of the last radiological assessment of measured lesions. Kaplan-Meier method was used.
Outcome measures
| Measure |
Part A
n=56 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
n=154 Participants
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Duration of Complete Response (DOCR) (Parts B and C)
|
NA Months
Median and 95% CI were not estimable due to insufficient number of participants with event.
|
NA Months
Median and 95% CI were not estimable due to insufficient number of participants with event.
|
SECONDARY outcome
Timeframe: Months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42Population: For Parts B and C, the full analysis set includes all participants who were enrolled and received any amount of the combination therapy in the study.
EFS was defined as the time from the start of study treatment to the first documentation of objective tumor progression, death due to any cause, or receipt of subsequent anticancer therapy to treat residual or progressive disease, whichever occurred first. The determination of antitumor activity will be based on objective response assessments made according to Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016). Participants without progression or death were censored on the date of the last radiological assessment of measured lesions. EFS rate was percentage of participants with EFS.
Outcome measures
| Measure |
Part A
n=57 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
n=154 Participants
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Event Free Survival (EFS) Rate (Parts B and C)
Month 3
|
98.25 Percentage of participants
Interval 88.19 to 99.75
|
100 Percentage of participants
Interval 100.0 to 100.0
|
|
Event Free Survival (EFS) Rate (Parts B and C)
Month 6
|
98.25 Percentage of participants
Interval 88.19 to 99.75
|
98.66 Percentage of participants
Interval 94.74 to 99.66
|
|
Event Free Survival (EFS) Rate (Parts B and C)
Month 9
|
94.67 Percentage of participants
Interval 84.39 to 98.25
|
98.66 Percentage of participants
Interval 94.74 to 99.66
|
|
Event Free Survival (EFS) Rate (Parts B and C)
Month 12
|
92.89 Percentage of participants
Interval 82.15 to 97.27
|
98.66 Percentage of participants
Interval 94.74 to 99.66
|
|
Event Free Survival (EFS) Rate (Parts B and C)
Month 15
|
91.03 Percentage of participants
Interval 79.77 to 96.17
|
97.95 Percentage of participants
Interval 93.79 to 99.34
|
|
Event Free Survival (EFS) Rate (Parts B and C)
Month 18
|
91.03 Percentage of participants
Interval 79.77 to 96.17
|
96.46 Percentage of participants
Interval 91.7 to 98.51
|
|
Event Free Survival (EFS) Rate (Parts B and C)
Month 21
|
86.89 Percentage of participants
Interval 74.38 to 93.55
|
96.46 Percentage of participants
Interval 91.7 to 98.51
|
|
Event Free Survival (EFS) Rate (Parts B and C)
Month 24
|
86.89 Percentage of participants
Interval 74.38 to 93.55
|
95.62 Percentage of participants
Interval 90.49 to 98.02
|
|
Event Free Survival (EFS) Rate (Parts B and C)
Month 27
|
86.89 Percentage of participants
Interval 74.38 to 93.55
|
94.72 Percentage of participants
Interval 89.19 to 97.46
|
|
Event Free Survival (EFS) Rate (Parts B and C)
Month 30
|
86.89 Percentage of participants
Interval 74.38 to 93.55
|
94.72 Percentage of participants
Interval 89.19 to 97.46
|
|
Event Free Survival (EFS) Rate (Parts B and C)
Month 33
|
84.54 Percentage of participants
Interval 71.29 to 92.01
|
94.72 Percentage of participants
Interval 89.19 to 97.46
|
|
Event Free Survival (EFS) Rate (Parts B and C)
Month 36
|
84.54 Percentage of participants
Interval 71.29 to 92.01
|
94.72 Percentage of participants
Interval 89.19 to 97.46
|
|
Event Free Survival (EFS) Rate (Parts B and C)
Month 39
|
84.54 Percentage of participants
Interval 71.29 to 92.01
|
94.72 Percentage of participants
Interval 89.19 to 97.46
|
|
Event Free Survival (EFS) Rate (Parts B and C)
Month 42
|
84.54 Percentage of participants
Interval 71.29 to 92.01
|
—
|
SECONDARY outcome
Timeframe: At months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 from the start of study treatmentPopulation: For Parts B and C, the full analysis set includes all participants who were enrolled and received any amount of the combination therapy in the study.
PFS was defined as the time from start of study treatment to first documentation of objective tumor progression or death. The determination of antitumor activity will be based on objective response assessments made according to Lugano Classification Revised Staging System for malignant lymphoma (Cheson 2014) with the incorporation of LYRIC (Cheson 2016). Participants without progression or death were censored on the date of the last radiological assessment of measured lesions. Kaplan-Meier method was used.
Outcome measures
| Measure |
Part A
n=57 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
n=154 Participants
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
PFS Rate (Parts B and C)
Month 3
|
100 Percentage of participants
Interval 100.0 to 100.0
|
100 Percentage of participants
Interval 100.0 to 100.0
|
|
PFS Rate (Parts B and C)
Month 6
|
100 Percentage of participants
Interval 100.0 to 100.0
|
100 Percentage of participants
Interval 100.0 to 100.0
|
|
PFS Rate (Parts B and C)
Month 9
|
96.36 Percentage of participants
Interval 86.23 to 99.08
|
100 Percentage of participants
Interval 100.0 to 100.0
|
|
PFS Rate (Parts B and C)
Month 12
|
94.55 Percentage of participants
Interval 84.04 to 98.21
|
100 Percentage of participants
Interval 100.0 to 100.0
|
|
PFS Rate (Parts B and C)
Month 21
|
88.44 Percentage of participants
Interval 76.0 to 94.65
|
97.77 Percentage of participants
Interval 93.26 to 99.28
|
|
PFS Rate (Parts B and C)
Month 24
|
88.44 Percentage of participants
Interval 76.0 to 94.65
|
96.92 Percentage of participants
Interval 91.99 to 98.84
|
|
PFS Rate (Parts B and C)
Month 27
|
88.44 Percentage of participants
Interval 76.0 to 94.65
|
96.01 Percentage of participants
Interval 90.64 to 98.33
|
|
PFS Rate (Parts B and C)
Month 30
|
88.44 Percentage of participants
Interval 76.0 to 94.65
|
96.01 Percentage of participants
Interval 90.64 to 98.33
|
|
PFS Rate (Parts B and C)
Month 33
|
86.05 Percentage of participants
Interval 72.8 to 93.14
|
96.01 Percentage of participants
Interval 90.64 to 98.33
|
|
PFS Rate (Parts B and C)
Month 36
|
86.05 Percentage of participants
Interval 72.8 to 93.14
|
96.01 Percentage of participants
Interval 90.64 to 98.33
|
|
PFS Rate (Parts B and C)
Month 39
|
86.05 Percentage of participants
Interval 72.8 to 93.14
|
96.01 Percentage of participants
Interval 90.64 to 98.33
|
|
PFS Rate (Parts B and C)
Month 42
|
86.05 Percentage of participants
Interval 72.8 to 93.14
|
—
|
|
PFS Rate (Parts B and C)
Month 15
|
92.65 Percentage of participants
Interval 81.59 to 97.18
|
99.29 Percentage of participants
Interval 95.04 to 99.9
|
|
PFS Rate (Parts B and C)
Month 18
|
92.65 Percentage of participants
Interval 81.59 to 97.18
|
97.77 Percentage of participants
Interval 93.26 to 99.28
|
SECONDARY outcome
Timeframe: At months 3, 6, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39 and 42 from the start of study treatmentPopulation: For Parts B and C, the full analysis set includes all participants who were enrolled and received any amount of the combination therapy in the study.
OS was defined as the time from start of study treatment to date of death due to any cause. In the absence of confirmation of death, survival time was censored at the last date the participant was known to be alive. Kaplan-Meier method was used.
Outcome measures
| Measure |
Part A
n=57 Participants
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part C
n=154 Participants
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|
|
Overall Survival (OS) Rate (Parts B and C)
Month 3
|
100 Percentage of participants
Interval 100.0 to 100.0
|
100 Percentage of participants
Interval 100.0 to 100.0
|
|
Overall Survival (OS) Rate (Parts B and C)
Month 6
|
100 Percentage of participants
Interval 100.0 to 100.0
|
100 Percentage of participants
Interval 100.0 to 100.0
|
|
Overall Survival (OS) Rate (Parts B and C)
Month 9
|
100 Percentage of participants
Interval 100.0 to 100.0
|
100 Percentage of participants
Interval 100.0 to 100.0
|
|
Overall Survival (OS) Rate (Parts B and C)
Month 12
|
98.25 Percentage of participants
Interval 88.19 to 99.75
|
100 Percentage of participants
Interval 100.0 to 100.0
|
|
Overall Survival (OS) Rate (Parts B and C)
Month 15
|
98.25 Percentage of participants
Interval 88.19 to 99.75
|
100 Percentage of participants
Interval 100.0 to 100.0
|
|
Overall Survival (OS) Rate (Parts B and C)
Month 18
|
98.25 Percentage of participants
Interval 88.19 to 99.75
|
100 Percentage of participants
Interval 100.0 to 100.0
|
|
Overall Survival (OS) Rate (Parts B and C)
Month 21
|
98.25 Percentage of participants
Interval 88.19 to 99.75
|
100 Percentage of participants
Interval 100.0 to 100.0
|
|
Overall Survival (OS) Rate (Parts B and C)
Month 24
|
98.25 Percentage of participants
Interval 88.19 to 99.75
|
100 Percentage of participants
Interval 100.0 to 100.0
|
|
Overall Survival (OS) Rate (Parts B and C)
Month 27
|
98.25 Percentage of participants
Interval 88.19 to 99.75
|
100 Percentage of participants
Interval 100.0 to 100.0
|
|
Overall Survival (OS) Rate (Parts B and C)
Month 30
|
98.25 Percentage of participants
Interval 88.19 to 99.75
|
100 Percentage of participants
Interval 100.0 to 100.0
|
|
Overall Survival (OS) Rate (Parts B and C)
Month 33
|
98.25 Percentage of participants
Interval 88.19 to 99.75
|
98.73 Percentage of participants
Interval 91.35 to 99.82
|
|
Overall Survival (OS) Rate (Parts B and C)
Month 36
|
98.25 Percentage of participants
Interval 88.19 to 99.75
|
98.73 Percentage of participants
Interval 91.35 to 99.82
|
|
Overall Survival (OS) Rate (Parts B and C)
Month 39
|
98.25 Percentage of participants
Interval 88.19 to 99.75
|
98.73 Percentage of participants
Interval 91.35 to 99.82
|
|
Overall Survival (OS) Rate (Parts B and C)
Month 42
|
98.25 Percentage of participants
Interval 88.19 to 99.75
|
98.73 Percentage of participants
Interval 91.35 to 99.82
|
Adverse Events
Part A
Serious events: 19 serious events
Other events: 40 other events
Deaths: 2 deaths
Part B
Serious events: 15 serious events
Other events: 57 other events
Deaths: 1 deaths
Part C
Serious events: 29 serious events
Other events: 153 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Part A
n=40 participants at risk
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part B
n=57 participants at risk
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage II bulky mediastinal disease and Stage III or IV cHL.
|
Part C
n=154 participants at risk
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
12.5%
5/40 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Acute left ventricular failure
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 congestive
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Pericardial effusion
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Faecaloma
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haematochezia
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Mouth haemorrhage
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.3%
3/57 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.9%
6/154 • Number of events 7 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Drug-induced liver injury
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Catheter site infection
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 infection
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis salmonella
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Meningitis aseptic
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
10.0%
4/40 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 fungal
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Soft tissue infection
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral tonsillitis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Accidental overdose
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Overdose
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Toxicity to various agents
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Diabetic ketoacidosis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Type 1 diabetes mellitus
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Immune-mediated lung disease
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.3%
3/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Pulmonary embolism
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Pyoderma gangrenosum
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 macular
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 morbilliform
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Toxic skin eruption
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Urticaria
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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=40 participants at risk
A+AVD (brentuximab vedotin plus doxorubicin, vinblastine, and dacarbazine) in participants with advanced stage classical Hodgkin lymphoma (cHL).
|
Part B
n=57 participants at risk
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage II bulky mediastinal disease and Stage III or IV cHL.
|
Part C
n=154 participants at risk
AN+AD (brentuximab vedotin and nivolumab plus doxorubicin and dacarbazine) in participants with Stage I or II cHL with non-bulky mediastinal disease.
|
|---|---|---|---|
|
Eye disorders
Lacrimation increased
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.3%
3/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Eye disorders
Photophobia
|
2.5%
1/40 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Eye disorders
Photopsia
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Eye disorders
Uveitis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Disturbance in attention
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
2.6%
4/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
25.0%
10/40 • Number of events 12 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.5%
6/57 • Number of events 7 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.4%
16/154 • Number of events 18 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Dysaesthesia
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
10.0%
4/40 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.5%
6/57 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.2%
8/154 • Number of events 10 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 folate deficiency
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Eosinophilia
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Increased tendency to bruise
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Iron deficiency anaemia
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Leukopenia
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 9 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Lymphadenitis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Lymphadenopathy
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Lymphopenia
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 7 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
7.5%
3/40 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.5%
6/57 • Number of events 10 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
12.3%
19/154 • Number of events 22 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Splenomegaly
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Atrial thrombosis
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Cardiac flutter
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Palpitations
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.2%
8/154 • Number of events 9 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Sinus tachycardia
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.9%
6/154 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Tachycardia
|
10.0%
4/40 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.9%
3/154 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Ear congestion
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Ear pain
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
External ear inflammation
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Tinnitus
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Vertigo
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Endocrine disorders
Goitre
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
7/154 • Number of events 8 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
8.8%
5/57 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.5%
10/154 • Number of events 10 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Endocrine disorders
Immune-mediated thyroiditis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Endocrine disorders
Thyroid mass
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Eye disorders
Chalazion
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Eye disorders
Dry eye
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.2%
5/154 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Eye disorders
Epiretinal membrane
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Eye disorders
Eye pain
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Eye disorders
Eye pruritus
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Eye disorders
Vision blurred
|
10.0%
4/40 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.5%
6/57 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
7/154 • Number of events 7 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Eye disorders
Visual impairment
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Eye disorders
Vitreous detachment
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Eye disorders
Xerophthalmia
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.9%
3/154 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
2.6%
4/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
25.0%
10/40 • Number of events 11 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.5%
6/57 • Number of events 11 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.7%
15/154 • Number of events 17 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Colitis
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.3%
3/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Constipation
|
45.0%
18/40 • Number of events 22 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
38.6%
22/57 • Number of events 24 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
44.8%
69/154 • Number of events 86 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dental caries
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
32.5%
13/40 • Number of events 17 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
45.6%
26/57 • Number of events 33 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
24.7%
38/154 • Number of events 49 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dry mouth
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.8%
9/154 • Number of events 9 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.5%
6/57 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.7%
15/154 • Number of events 16 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dysphagia
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Eructation
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
2.6%
4/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastritis
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
12.5%
5/40 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
8.8%
5/57 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
11.0%
17/154 • Number of events 17 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
7.0%
4/57 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
2.6%
4/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Hypoaesthesia oral
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Intussusception
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lip pain
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
70.0%
28/40 • Number of events 31 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
70.2%
40/57 • Number of events 58 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
68.2%
105/154 • Number of events 135 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Noninfective sialoadenitis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal dilatation
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oesophageal spasm
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral disorder
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral dysaesthesia
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Oral pain
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.2%
5/154 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Paraesthesia oral
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Stomatitis
|
22.5%
9/40 • Number of events 11 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
15.8%
9/57 • Number of events 9 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.9%
23/154 • Number of events 27 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
22.5%
9/40 • Number of events 12 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
28.1%
16/57 • Number of events 17 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
16.2%
25/154 • Number of events 33 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Asthenia
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Axillary pain
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Catheter site bruise
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Catheter site erythema
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Catheter site inflammation
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Catheter site pain
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.9%
6/154 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Catheter site rash
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Chest discomfort
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.9%
6/154 • Number of events 7 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Chest pain
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Chills
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
8.8%
5/57 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.9%
6/154 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Face oedema
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Facial pain
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
37.5%
15/40 • Number of events 16 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
50.9%
29/57 • Number of events 36 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
48.1%
74/154 • Number of events 83 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Feeling cold
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Feeling hot
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Generalised oedema
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Influenza like illness
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.9%
6/154 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Infusion site pain
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Infusion site pruritus
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Infusion site rash
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Injection site pain
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Injection site reaction
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Mucosal inflammation
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.3%
3/57 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.2%
8/154 • Number of events 8 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Oedema peripheral
|
12.5%
5/40 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.3%
3/57 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.9%
6/154 • Number of events 7 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Pain
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
7.0%
4/57 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.9%
6/154 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Puncture site swelling
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
20.0%
8/40 • Number of events 8 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.5%
6/57 • Number of events 9 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
13.6%
21/154 • Number of events 28 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Swelling
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Swelling face
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
General disorders
Temperature intolerance
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hepatitis acute
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
2.6%
4/154 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Immune system disorders
Contrast media allergy
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.3%
3/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
15.6%
24/154 • Number of events 27 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Conjunctivitis bacterial
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Device related infection
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Ear infection
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Epstein-Barr virus infection
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Fungal foot infection
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Furuncle
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Gastroenteritis norovirus
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Herpes zoster
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Infected bite
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Nail bed infection
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Omphalitis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.3%
3/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
2.6%
4/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 herpes
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Penile infection
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Peripheral nerve infection
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
22.5%
9/40 • Number of events 9 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
8.8%
5/57 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
8.4%
13/154 • Number of events 14 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Pilonidal disease
|
2.5%
1/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
2.6%
4/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 viral
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Prostate infection
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Skin infection
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Soft tissue infection
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 infection
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Systemic candida
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Tinea pedis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 abscess
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.3%
3/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
7.1%
11/154 • Number of events 13 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.5%
6/57 • Number of events 8 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.2%
5/154 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Vaginal infection
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
7.0%
4/57 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Head injury
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
9.1%
14/154 • Number of events 19 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Injection related reaction
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Radius fracture
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Seroma
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 laceration
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Spinal compression fracture
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Sunburn
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Thermal burn
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Wound
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
10.0%
4/40 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
15.8%
9/57 • Number of events 11 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
21.4%
33/154 • Number of events 50 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
7.1%
11/154 • Number of events 16 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
12.3%
7/57 • Number of events 8 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
17.5%
27/154 • Number of events 36 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
2.6%
4/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 7 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.9%
3/154 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Blood glucose increased
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase increased
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.9%
3/154 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
C-reactive protein increased
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Fibrin D dimer increased
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Glomerular filtration rate decreased
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Glycosylated haemoglobin increased
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Heart rate irregular
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
International normalised ratio increased
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.9%
6/154 • Number of events 7 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Liver function test increased
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Lymphocyte count decreased
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.9%
3/154 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
12.5%
5/40 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
8.8%
5/57 • Number of events 7 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.2%
5/154 • Number of events 9 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Neutrophil count increased
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Transaminases increased
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Weight decreased
|
15.0%
6/40 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
8.8%
5/57 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.5%
10/154 • Number of events 10 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
Weight increased
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.5%
6/57 • Number of events 7 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Investigations
White blood cell count increased
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
27.5%
11/40 • Number of events 12 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
15.8%
9/57 • Number of events 10 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.3%
22/154 • Number of events 29 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
12.5%
5/40 • Number of events 25 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
7.0%
4/57 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.2%
5/154 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Diabetes mellitus
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Fluid retention
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Food aversion
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Gout
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
7.0%
4/57 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.9%
3/154 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Hyperlipasaemia
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
10.0%
4/40 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.9%
6/154 • Number of events 8 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Hypoalbuminaemia
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Hypocalcaemia
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
10.0%
4/40 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
15.8%
9/57 • Number of events 13 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.2%
5/154 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
7.5%
3/40 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Increased appetite
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
15.0%
6/40 • Number of events 7 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
12.3%
7/57 • Number of events 9 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.4%
16/154 • Number of events 19 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
12.5%
5/40 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.5%
6/57 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.4%
16/154 • Number of events 16 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Bone pain
|
30.0%
12/40 • Number of events 14 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
17.5%
10/57 • Number of events 10 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.5%
10/154 • Number of events 11 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Coccydynia
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Costochondritis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Flank pain
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Joint swelling
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Limb discomfort
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Muscle spasms
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.3%
3/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
2.6%
4/154 • Number of events 7 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Musculoskeletal chest pain
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
2.6%
4/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Musculoskeletal discomfort
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Musculoskeletal pain
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Musculoskeletal stiffness
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
17.5%
7/40 • Number of events 8 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.0%
8/57 • Number of events 12 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
7.8%
12/154 • Number of events 12 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.3%
3/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
2.6%
4/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Osteoporosis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
17.5%
7/40 • Number of events 8 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
7.0%
4/57 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.8%
9/154 • Number of events 11 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 jaw
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.9%
3/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Trigger finger
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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)
Cancer pain
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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)
Haemangioma of skin
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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)
Tumour thrombosis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
32.5%
13/40 • Number of events 14 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
26.3%
15/57 • Number of events 20 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
23.4%
36/154 • Number of events 46 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Intensive care unit acquired weakness
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Memory impairment
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
5.0%
2/40 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
4.5%
7/154 • Number of events 9 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Parosmia
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
10.0%
4/40 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 sensorimotor neuropathy
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
62.5%
25/40 • Number of events 34 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
45.6%
26/57 • Number of events 34 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
46.8%
72/154 • Number of events 79 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Peroneal nerve palsy
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Somnolence
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Nervous system disorders
Tremor
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Product Issues
Device occlusion
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Anxiety
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
14.0%
8/57 • Number of events 9 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.4%
16/154 • Number of events 16 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
2.6%
4/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Drug abuse
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Insomnia
|
27.5%
11/40 • Number of events 11 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
10.5%
6/57 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
13.6%
21/154 • Number of events 21 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Restlessness
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Dysuria
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Immune-mediated nephritis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Lower urinary tract symptoms
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Micturition urgency
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Pollakiuria
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 retention
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 tract pain
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Urine abnormality
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Amenorrhoea
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Heavy menstrual bleeding
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Intermenstrual bleeding
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.3%
3/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Pelvic pain
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Penile pain
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Premature menopause
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
7.0%
4/57 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Reproductive system and breast disorders
Vulvovaginal inflammation
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Chronic obstructive pulmonary disease
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
12.3%
7/57 • Number of events 7 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
11.7%
18/154 • Number of events 19 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
2.6%
4/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
15.0%
6/40 • Number of events 8 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
17.5%
10/57 • Number of events 11 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
16.9%
26/154 • Number of events 29 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 exertional
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.2%
8/154 • Number of events 8 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
10.0%
4/40 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.9%
6/154 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Nasal congestion
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
6.5%
10/154 • Number of events 10 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
7.5%
3/40 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
8.4%
13/154 • Number of events 14 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Paranasal sinus discomfort
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Paranasal sinus hypersecretion
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Pharyngeal swelling
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Pleuritic pain
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Pneumothorax
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.3%
3/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Pulmonary embolism
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Respiratory failure
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Respiratory tract congestion
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Rhinitis allergic
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
7.0%
4/57 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.2%
5/154 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.9%
3/154 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Sinus congestion
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Sinus disorder
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Sleep apnoea syndrome
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Sneezing
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 resistance syndrome
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
5.0%
2/40 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
8.8%
5/57 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Wheezing
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Acne
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
30.0%
12/40 • Number of events 12 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
36.8%
21/57 • Number of events 21 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
22.1%
34/154 • Number of events 34 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Decubitus ulcer
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Dermal cyst
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Dermatitis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Dermatitis acneiform
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
7.0%
4/57 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.9%
3/154 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Dermatitis atopic
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Dermatitis bullous
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Dermatitis contact
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Drug eruption
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.2%
5/154 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Eczema
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Erythema
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.9%
3/154 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Hidradenitis
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Hyperhidrosis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
5.3%
3/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.9%
6/154 • Number of events 7 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Ingrowing nail
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Nail discolouration
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
2.6%
4/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Nail disorder
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.2%
5/154 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Onychomadesis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Pain of skin
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Palmar-plantar erythrodysaesthesia syndrome
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Papule
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Penile ulceration
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Photosensitivity reaction
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
5.0%
2/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
8.8%
5/57 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
8.4%
13/154 • Number of events 13 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Psoriasis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
2.5%
1/40 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
7.0%
4/57 • Number of events 6 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
8.4%
13/154 • Number of events 15 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 erythematous
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.9%
3/154 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 macular
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
15.0%
6/40 • Number of events 8 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
19.3%
11/57 • Number of events 12 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
13.0%
20/154 • Number of events 28 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 morbilliform
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 papular
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 pruritic
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 vesicular
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 burning sensation
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 exfoliation
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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 hyperpigmentation
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Umbilical erythema
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Urticaria
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
Urticaria chronic
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Catheter placement
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.8%
1/57 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Cyst drainage
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/154 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Vocal cord polypectomy
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Surgical and medical procedures
Wisdom teeth removal
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Cyanosis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Embolism
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Flushing
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.2%
5/154 • Number of events 5 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Hot flush
|
7.5%
3/40 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
12.3%
7/57 • Number of events 7 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
7.1%
11/154 • Number of events 12 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypertension
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
7.0%
4/57 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.3%
2/154 • Number of events 2 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Hypotension
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
3.5%
2/57 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
2.6%
4/154 • Number of events 4 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Phlebitis
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
1.9%
3/154 • Number of events 3 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Superficial vein thrombosis
|
2.5%
1/40 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
|
Vascular disorders
Withdrawal hypertension
|
0.00%
0/40 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.00%
0/57 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 months.
The population for all-cause mortality and adverse events includes participants who received at least one dose of study drug.
|
0.65%
1/154 • Number of events 1 • All-Cause Mortality: Up to 54.5 Months, Serious Adverse Events, and Non-Serious Adverse Events were followed for up to 8.9 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