Trial Outcomes & Findings for Nivolumab With or Without Ipilimumab in Advanced Metastatic Cancer (NCT NCT03651271)
NCT ID: NCT03651271
Last Updated: 2024-02-07
Results Overview
CBR is defined as the percentage of participants who show clinical benefit, defined as obtaining a complete response (CR; disappearance of all target and non-target lesions), partial response (PR; ≥ 30% decrease in the sum of the longest diameter of target lesions), or stable disease (SD) for ≥ 6 months, as determined by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
100 participants
Primary outcome timeframe
Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy, whichever occurred first, up to 43 months
Results posted on
2024-02-07
Participant Flow
Participant milestones
| Measure |
"Hot" Tumors for Advanced Metastatic Cancer
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At the occurrence of disease progression (PD), participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV every 3 weeks (Q3W). Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV every 4 weeks (Q4W) until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Metastatic Cancer
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab and Combination for Metastatic Cancer: For nivolumab and ipilimumab combination therapy, nivolumab will be administered at 360 mg IV Q3W, and ipilimumab will be administered at 1 mg/kg IV Q3W for the first 2 doses and then Q6W for the 3rd and 4th doses, followed by single-agent nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Hot" Tumors for Advanced Prostate Cancer
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort A
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort A will receive nivolumab 1 mg/kg Q3W and ipilimumab 3 mg/kg every 6 weeks (Q6W) for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If the safety profile of Prostate Cohort B is deemed unacceptable, an additional 10 participants will be enrolled in Prostate Cohort A.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort B
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort B will receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If Prostate Cohort B is determined to have a tolerable safety profile, an additional 10 participants will be enrolled to receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
72
|
1
|
5
|
15
|
|
Overall Study
COMPLETED
|
1
|
13
|
1
|
1
|
8
|
|
Overall Study
NOT COMPLETED
|
6
|
59
|
0
|
4
|
7
|
Reasons for withdrawal
| Measure |
"Hot" Tumors for Advanced Metastatic Cancer
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At the occurrence of disease progression (PD), participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV every 3 weeks (Q3W). Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV every 4 weeks (Q4W) until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Metastatic Cancer
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab and Combination for Metastatic Cancer: For nivolumab and ipilimumab combination therapy, nivolumab will be administered at 360 mg IV Q3W, and ipilimumab will be administered at 1 mg/kg IV Q3W for the first 2 doses and then Q6W for the 3rd and 4th doses, followed by single-agent nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Hot" Tumors for Advanced Prostate Cancer
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort A
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort A will receive nivolumab 1 mg/kg Q3W and ipilimumab 3 mg/kg every 6 weeks (Q6W) for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If the safety profile of Prostate Cohort B is deemed unacceptable, an additional 10 participants will be enrolled in Prostate Cohort A.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort B
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort B will receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If Prostate Cohort B is determined to have a tolerable safety profile, an additional 10 participants will be enrolled to receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity.
|
|---|---|---|---|---|---|
|
Overall Study
Death
|
4
|
37
|
0
|
2
|
6
|
|
Overall Study
Lost to Follow-up
|
1
|
5
|
0
|
1
|
0
|
|
Overall Study
Physician Decision
|
0
|
2
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
15
|
0
|
0
|
1
|
|
Overall Study
Patient medically unable to continue
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Two participants did not have an ECOG performance score recorded at Screening and are excluded from analysis.
Baseline characteristics by cohort
| Measure |
"Hot" Tumors for Advanced Metastatic Cancer
n=7 Participants
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Metastatic Cancer
n=72 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab and Combination for Metastatic Cancer: For nivolumab and ipilimumab combination therapy, nivolumab will be administered at 360 mg IV Q3W, and ipilimumab will be administered at 1 mg/kg IV Q3W for the first 2 doses and then Q6W for the 3rd and 4th doses, followed by single-agent nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Hot" Tumors for Advanced Prostate Cancer
n=1 Participants
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort A
n=5 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort A will receive nivolumab 1 mg/kg Q3W and ipilimumab 3 mg/kg every 6 weeks (Q6W) for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If the safety profile of Prostate Cohort B is deemed unacceptable, an additional 10 participants will be enrolled in Prostate Cohort A.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort B
n=15 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort B will receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If Prostate Cohort B is determined to have a tolerable safety profile, an additional 10 participants will be enrolled to receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=7 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=100 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=7 Participants
|
46 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=15 Participants
|
57 Participants
n=100 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=7 Participants
|
26 Participants
n=72 Participants
|
1 Participants
n=1 Participants
|
4 Participants
n=5 Participants
|
11 Participants
n=15 Participants
|
43 Participants
n=100 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=7 Participants
|
35 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
36 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=7 Participants
|
37 Participants
n=72 Participants
|
1 Participants
n=1 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=15 Participants
|
64 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=7 Participants
|
9 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
9 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=7 Participants
|
63 Participants
n=72 Participants
|
1 Participants
n=1 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=15 Participants
|
91 Participants
n=100 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=7 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=7 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=7 Participants
|
5 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
5 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=7 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=7 Participants
|
7 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=15 Participants
|
9 Participants
n=100 Participants
|
|
Race (NIH/OMB)
White
|
6 Participants
n=7 Participants
|
45 Participants
n=72 Participants
|
1 Participants
n=1 Participants
|
3 Participants
n=5 Participants
|
14 Participants
n=15 Participants
|
69 Participants
n=100 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=7 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
0 Participants
n=100 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=7 Participants
|
15 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
17 Participants
n=100 Participants
|
|
Region of Enrollment
United States
|
7 participants
n=7 Participants
|
72 participants
n=72 Participants
|
1 participants
n=1 Participants
|
5 participants
n=5 Participants
|
15 participants
n=15 Participants
|
100 participants
n=100 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Score
0
|
4 Participants
n=7 Participants • Two participants did not have an ECOG performance score recorded at Screening and are excluded from analysis.
|
23 Participants
n=70 Participants • Two participants did not have an ECOG performance score recorded at Screening and are excluded from analysis.
|
0 Participants
n=1 Participants • Two participants did not have an ECOG performance score recorded at Screening and are excluded from analysis.
|
0 Participants
n=5 Participants • Two participants did not have an ECOG performance score recorded at Screening and are excluded from analysis.
|
4 Participants
n=15 Participants • Two participants did not have an ECOG performance score recorded at Screening and are excluded from analysis.
|
31 Participants
n=98 Participants • Two participants did not have an ECOG performance score recorded at Screening and are excluded from analysis.
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Score
1
|
3 Participants
n=7 Participants • Two participants did not have an ECOG performance score recorded at Screening and are excluded from analysis.
|
47 Participants
n=70 Participants • Two participants did not have an ECOG performance score recorded at Screening and are excluded from analysis.
|
1 Participants
n=1 Participants • Two participants did not have an ECOG performance score recorded at Screening and are excluded from analysis.
|
5 Participants
n=5 Participants • Two participants did not have an ECOG performance score recorded at Screening and are excluded from analysis.
|
11 Participants
n=15 Participants • Two participants did not have an ECOG performance score recorded at Screening and are excluded from analysis.
|
67 Participants
n=98 Participants • Two participants did not have an ECOG performance score recorded at Screening and are excluded from analysis.
|
|
Primary Tumor Type
Prostate
|
0 Participants
n=7 Participants
|
12 Participants
n=72 Participants
|
1 Participants
n=1 Participants
|
5 Participants
n=5 Participants
|
15 Participants
n=15 Participants
|
33 Participants
n=100 Participants
|
|
Primary Tumor Type
Head and Neck
|
3 Participants
n=7 Participants
|
6 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
9 Participants
n=100 Participants
|
|
Primary Tumor Type
Colorectal
|
0 Participants
n=7 Participants
|
7 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
7 Participants
n=100 Participants
|
|
Primary Tumor Type
Sarcoma
|
0 Participants
n=7 Participants
|
7 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
7 Participants
n=100 Participants
|
|
Primary Tumor Type
Ovarian
|
1 Participants
n=7 Participants
|
5 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
6 Participants
n=100 Participants
|
|
Primary Tumor Type
Uterine
|
0 Participants
n=7 Participants
|
4 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
4 Participants
n=100 Participants
|
|
Primary Tumor Type
Breast
|
0 Participants
n=7 Participants
|
3 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
3 Participants
n=100 Participants
|
|
Primary Tumor Type
Hepatocellular cholangiocarcinoma
|
0 Participants
n=7 Participants
|
3 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
3 Participants
n=100 Participants
|
|
Primary Tumor Type
Neuroendocrine
|
0 Participants
n=7 Participants
|
3 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
3 Participants
n=100 Participants
|
|
Primary Tumor Type
Renal
|
1 Participants
n=7 Participants
|
2 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
3 Participants
n=100 Participants
|
|
Primary Tumor Type
Thyroid
|
0 Participants
n=7 Participants
|
3 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
3 Participants
n=100 Participants
|
|
Primary Tumor Type
Urethral
|
1 Participants
n=7 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=100 Participants
|
|
Primary Tumor Type
Gastroesophageal
|
1 Participants
n=7 Participants
|
0 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=100 Participants
|
|
Primary Tumor Type
Cervix
|
0 Participants
n=7 Participants
|
2 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=100 Participants
|
|
Primary Tumor Type
Gastric
|
0 Participants
n=7 Participants
|
2 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=100 Participants
|
|
Primary Tumor Type
Non-small cell lung
|
0 Participants
n=7 Participants
|
2 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=100 Participants
|
|
Primary Tumor Type
Pancreatic
|
0 Participants
n=7 Participants
|
2 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=100 Participants
|
|
Primary Tumor Type
Pelvic
|
0 Participants
n=7 Participants
|
2 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=100 Participants
|
|
Primary Tumor Type
Peritoneal
|
0 Participants
n=7 Participants
|
2 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
2 Participants
n=100 Participants
|
|
Primary Tumor Type
Hepatocellular carcinoma
|
0 Participants
n=7 Participants
|
1 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=100 Participants
|
|
Primary Tumor Type
Merkel cell
|
0 Participants
n=7 Participants
|
1 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=100 Participants
|
|
Primary Tumor Type
Penile
|
0 Participants
n=7 Participants
|
1 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=100 Participants
|
|
Primary Tumor Type
Retroperitoneal teratoma
|
0 Participants
n=7 Participants
|
1 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=100 Participants
|
|
Primary Tumor Type
Papilla of vater
|
0 Participants
n=7 Participants
|
1 Participants
n=72 Participants
|
0 Participants
n=1 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=15 Participants
|
1 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy, whichever occurred first, up to 43 monthsCBR is defined as the percentage of participants who show clinical benefit, defined as obtaining a complete response (CR; disappearance of all target and non-target lesions), partial response (PR; ≥ 30% decrease in the sum of the longest diameter of target lesions), or stable disease (SD) for ≥ 6 months, as determined by Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
Outcome measures
| Measure |
"Hot" Tumors for Advanced Metastatic Cancer
n=7 Participants
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Metastatic Cancer
n=72 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab and Combination for Metastatic Cancer: For nivolumab and ipilimumab combination therapy, nivolumab will be administered at 360 mg IV Q3W, and ipilimumab will be administered at 1 mg/kg IV Q3W for the first 2 doses and then Q6W for the 3rd and 4th doses, followed by single-agent nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Hot" Tumors for Advanced Prostate Cancer
n=1 Participants
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort A
n=5 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort A will receive nivolumab 1 mg/kg Q3W and ipilimumab 3 mg/kg every 6 weeks (Q6W) for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If the safety profile of Prostate Cohort B is deemed unacceptable, an additional 10 participants will be enrolled in Prostate Cohort A.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort B
n=15 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort B will receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If Prostate Cohort B is determined to have a tolerable safety profile, an additional 10 participants will be enrolled to receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity.
|
|---|---|---|---|---|---|
|
Clinical Benefit Rate (CBR) of Nivolumab With or Without Ipilimumab
|
1 Participants
|
18 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: From initiation of study intervention through the 2nd on-treatment tumor biopsy, up to 8 monthsPopulation: Only CD8 low participants with an on-treatment biopsy are included in the analysis population for this outcome. Participants in the CD8 high arms and participants without an on-treatment biopsy are not evaluated for this outcome.
Percentage of participants in the nivolumab plus ipilimumab ("CD8 low") arm whose tumors convert from CD8 low (\<15%) to CD8 high (\>=15%) as measured by the percentage of tumoral CD8 cells. Participants in the CD8 high arms are not evaluated for this outcome. On-treatment biopsies for the advanced metastatic cancer cohort were scheduled for as early as possible after the 2nd and 4th doses of ipilimumab (Day 2 - 10 of Cycle 2 and Cycle 6, respectively). On-treatment biopsies for the advanced prostate cancer cohort were scheduled for within 3 days (+/-) of the 2nd and 4th doses of nivolumab (Day 22 of Cycle 1 and Cycle 2, respectively).
Outcome measures
| Measure |
"Hot" Tumors for Advanced Metastatic Cancer
n=39 Participants
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Metastatic Cancer
n=3 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab and Combination for Metastatic Cancer: For nivolumab and ipilimumab combination therapy, nivolumab will be administered at 360 mg IV Q3W, and ipilimumab will be administered at 1 mg/kg IV Q3W for the first 2 doses and then Q6W for the 3rd and 4th doses, followed by single-agent nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Hot" Tumors for Advanced Prostate Cancer
n=8 Participants
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort A
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort A will receive nivolumab 1 mg/kg Q3W and ipilimumab 3 mg/kg every 6 weeks (Q6W) for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If the safety profile of Prostate Cohort B is deemed unacceptable, an additional 10 participants will be enrolled in Prostate Cohort A.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort B
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort B will receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If Prostate Cohort B is determined to have a tolerable safety profile, an additional 10 participants will be enrolled to receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity.
|
|---|---|---|---|---|---|
|
Percentage of Participants Whose Tumors Convert From CD8 Low (<15% Tumoral CD8) to CD8 High (>=15%).
|
14 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: From signing informed consent (prior to Screening) through 100 days after last dose, up to 43 months.Investigators recorded adverse events (AEs) during each participant encounter. AE severity was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0, which grades AEs on a 1 to 5 scale: Grades 1 and 2 indicate mild to moderate events; Grade 3 denotes severe events; Grades 4 and 5 signify life-threatening or fatal outcomes. A TRAE is defined as any event that either occurs after the initiation of study intervention, having been absent at baseline, or, if present at baseline, appears to have worsened in severity or frequency, that is deemed 'Possibly', 'Probably', or 'Definitely' related to the intervention by the Investigator. All TRAEs were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only TRAEs that were related to a protocol mandated intervention, including those that occurred prior to being assigned to a study arm, were reported.
Outcome measures
| Measure |
"Hot" Tumors for Advanced Metastatic Cancer
n=7 Participants
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Metastatic Cancer
n=72 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab and Combination for Metastatic Cancer: For nivolumab and ipilimumab combination therapy, nivolumab will be administered at 360 mg IV Q3W, and ipilimumab will be administered at 1 mg/kg IV Q3W for the first 2 doses and then Q6W for the 3rd and 4th doses, followed by single-agent nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Hot" Tumors for Advanced Prostate Cancer
n=1 Participants
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort A
n=5 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort A will receive nivolumab 1 mg/kg Q3W and ipilimumab 3 mg/kg every 6 weeks (Q6W) for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If the safety profile of Prostate Cohort B is deemed unacceptable, an additional 10 participants will be enrolled in Prostate Cohort A.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort B
n=15 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort B will receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If Prostate Cohort B is determined to have a tolerable safety profile, an additional 10 participants will be enrolled to receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity.
|
|---|---|---|---|---|---|
|
Number of Participants With Treatment-related Adverse Events (TRAE)
Any Treatment-related adverse event (TRAE)
|
4 Participants
|
58 Participants
|
1 Participants
|
4 Participants
|
12 Participants
|
|
Number of Participants With Treatment-related Adverse Events (TRAE)
Grade 3 or Grade 4 TRAE
|
0 Participants
|
20 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants With Treatment-related Adverse Events (TRAE)
Grade 5 TRAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Treatment-related Adverse Events (TRAE)
Serious TRAE
|
0 Participants
|
10 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants With Treatment-related Adverse Events (TRAE)
TRAE leading to treatment discontinuation
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Initiation of study drug through radiographic progression or initiation of new anti-cancer therapy, whichever occurred first, up to 43 monthsObjective Response Rate (ORR) is defined as the percentage of participants who attain a best overall response of complete response (CR; disappearance of all target and non-target lesions) or partial response (PR; \>= 30% decrease in the sum of the longest diameter of target lesions), as determined by Response Evaluation Criteria in Solid Tumours (RECIST) version 1.1.
Outcome measures
| Measure |
"Hot" Tumors for Advanced Metastatic Cancer
n=7 Participants
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Metastatic Cancer
n=72 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab and Combination for Metastatic Cancer: For nivolumab and ipilimumab combination therapy, nivolumab will be administered at 360 mg IV Q3W, and ipilimumab will be administered at 1 mg/kg IV Q3W for the first 2 doses and then Q6W for the 3rd and 4th doses, followed by single-agent nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Hot" Tumors for Advanced Prostate Cancer
n=1 Participants
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort A
n=5 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort A will receive nivolumab 1 mg/kg Q3W and ipilimumab 3 mg/kg every 6 weeks (Q6W) for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If the safety profile of Prostate Cohort B is deemed unacceptable, an additional 10 participants will be enrolled in Prostate Cohort A.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort B
n=15 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort B will receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If Prostate Cohort B is determined to have a tolerable safety profile, an additional 10 participants will be enrolled to receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity.
|
|---|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
1 Participants
|
14 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Initiation of study drug through death, radiographic progression or initiation of new anti-cancer therapy, whichever occurred first, up to 43 monthsPFS is defined as the time from initiation of study intervention to the date of first documented radiographic progression of disease or date of death due to any cause, whichever occurred first. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Outcome measures
| Measure |
"Hot" Tumors for Advanced Metastatic Cancer
n=7 Participants
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Metastatic Cancer
n=72 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab and Combination for Metastatic Cancer: For nivolumab and ipilimumab combination therapy, nivolumab will be administered at 360 mg IV Q3W, and ipilimumab will be administered at 1 mg/kg IV Q3W for the first 2 doses and then Q6W for the 3rd and 4th doses, followed by single-agent nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Hot" Tumors for Advanced Prostate Cancer
n=1 Participants
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort A
n=5 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort A will receive nivolumab 1 mg/kg Q3W and ipilimumab 3 mg/kg every 6 weeks (Q6W) for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If the safety profile of Prostate Cohort B is deemed unacceptable, an additional 10 participants will be enrolled in Prostate Cohort A.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort B
n=15 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort B will receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If Prostate Cohort B is determined to have a tolerable safety profile, an additional 10 participants will be enrolled to receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity.
|
|---|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
2.0 months
Interval 1.1 to
Upper confidence limit is not estimable due to insufficient number of participants with events.
|
2.3 months
Interval 2.0 to 4.3
|
NA months
Median and confidence limits are not estimable due to insufficient number of participants with events.
|
3.7 months
Interval 1.1 to
Upper confidence limit is not estimable due to insufficient number of participants with events.
|
5.7 months
Interval 2.0 to 7.9
|
SECONDARY outcome
Timeframe: From initiation of study drug until death due to any cause, up to 43 monthsOS is defined as the time from initiation of study intervention until death due to any cause. Participants not reported as having died at the time of analysis were censored at the most recent contact date they were known to be alive.
Outcome measures
| Measure |
"Hot" Tumors for Advanced Metastatic Cancer
n=7 Participants
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Metastatic Cancer
n=72 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab and Combination for Metastatic Cancer: For nivolumab and ipilimumab combination therapy, nivolumab will be administered at 360 mg IV Q3W, and ipilimumab will be administered at 1 mg/kg IV Q3W for the first 2 doses and then Q6W for the 3rd and 4th doses, followed by single-agent nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Hot" Tumors for Advanced Prostate Cancer
n=1 Participants
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort A
n=5 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort A will receive nivolumab 1 mg/kg Q3W and ipilimumab 3 mg/kg every 6 weeks (Q6W) for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If the safety profile of Prostate Cohort B is deemed unacceptable, an additional 10 participants will be enrolled in Prostate Cohort A.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort B
n=15 Participants
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort B will receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If Prostate Cohort B is determined to have a tolerable safety profile, an additional 10 participants will be enrolled to receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity.
|
|---|---|---|---|---|---|
|
Overall Survival (OS)
|
15.8 months
Interval 12.1 to
Upper confidence limit is not estimable due to insufficient number of participants with events.
|
13.9 months
Interval 8.9 to 21.1
|
NA months
Median and confidence limits are not estimable due to insufficient number of participants with events.
|
NA months
Interval 1.1 to
Median and confidence limits are not estimable due to insufficient number of participants with events.
|
NA months
Interval 4.9 to
Median and confidence limits are not estimable due to insufficient number of participants with events.
|
Adverse Events
"Hot" Tumors for Advanced Metastatic Cancer
Serious events: 2 serious events
Other events: 7 other events
Deaths: 4 deaths
"Cold" Tumors for Advanced Metastatic Cancer
Serious events: 30 serious events
Other events: 71 other events
Deaths: 39 deaths
"Hot" Tumors for Advanced Prostate Cancer
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
"Cold" Tumors for Advanced Prostate Cancer Cohort A
Serious events: 2 serious events
Other events: 5 other events
Deaths: 2 deaths
"Cold" Tumors for Advanced Prostate Cancer Cohort B
Serious events: 8 serious events
Other events: 15 other events
Deaths: 6 deaths
Serious adverse events
| Measure |
"Hot" Tumors for Advanced Metastatic Cancer
n=7 participants at risk
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Metastatic Cancer
n=72 participants at risk
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab and Combination for Metastatic Cancer: For nivolumab and ipilimumab combination therapy, nivolumab will be administered at 360 mg IV Q3W, and ipilimumab will be administered at 1 mg/kg IV Q3W for the first 2 doses and then Q6W for the 3rd and 4th doses, followed by single-agent nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Hot" Tumors for Advanced Prostate Cancer
n=1 participants at risk
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort A
n=5 participants at risk
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort A will receive nivolumab 1 mg/kg Q3W and ipilimumab 3 mg/kg every 6 weeks (Q6W) for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If the safety profile of Prostate Cohort B is deemed unacceptable, an additional 10 participants will be enrolled in Prostate Cohort A.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort B
n=15 participants at risk
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort B will receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If Prostate Cohort B is determined to have a tolerable safety profile, an additional 10 participants will be enrolled to receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity.
|
|---|---|---|---|---|---|
|
Cardiac disorders
Cardio-respiratory arrest
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Endocrine disorders
Hypophysitis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Eye disorders
Retinal vascular disorder
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Eye disorders
Vision blurred
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Anal incontinence
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Oesophagitis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
General disorders
Fatigue
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
General disorders
Influenza like illness
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
General disorders
Pyrexia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
5.6%
4/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Pneumonia aspiration
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Sepsis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Amylase increased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Lipase increased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Musculoskeletal and connective tissue disorders
Rhabdomyolysis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Nervous system disorders
Syncope
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Immune-Mediated Enterocolitis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
3/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Cardiac disorders
Acute Myocardial Infarction
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Endocrine disorders
Adrenocortical Insufficiency Acute
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Endocrine disorders
Immune-Mediated Adrenal Insufficiency
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Hepatobiliary disorders
Immune-Mediated Hepatitis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Covid-19 Pneumonia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Blood Bilirubin Increased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Nervous system disorders
Guillain-Barre Syndrome
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Renal and urinary disorders
Urinary Retention
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Skin and subcutaneous tissue disorders
Medical Device Site Cellulitis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
Other adverse events
| Measure |
"Hot" Tumors for Advanced Metastatic Cancer
n=7 participants at risk
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Metastatic Cancer
n=72 participants at risk
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab and Combination for Metastatic Cancer: For nivolumab and ipilimumab combination therapy, nivolumab will be administered at 360 mg IV Q3W, and ipilimumab will be administered at 1 mg/kg IV Q3W for the first 2 doses and then Q6W for the 3rd and 4th doses, followed by single-agent nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Hot" Tumors for Advanced Prostate Cancer
n=1 participants at risk
Participants with ≥ 15% CD8 cells in their tumor biopsies (ie, CD8 high tumors) will be treated with single-agent nivolumab. At PD, participants will be allowed to add ipilimumab.
Nivolumab Monotherapy: Single-agent nivolumab will be administered at 360 mg IV Q3W. Participants who continue to show clinical benefit after the first disease assessment will receive nivolumab 480 mg IV Q4W until PD or intolerable toxicity.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort A
n=5 participants at risk
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (3 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort A will receive nivolumab 1 mg/kg Q3W and ipilimumab 3 mg/kg every 6 weeks (Q6W) for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If the safety profile of Prostate Cohort B is deemed unacceptable, an additional 10 participants will be enrolled in Prostate Cohort A.
|
"Cold" Tumors for Advanced Prostate Cancer Cohort B
n=15 participants at risk
Participants with \< 15% CD8 cells in their tumor biopsies (ie, CD8 low tumors) will be treated with nivolumab in combination with ipilimumab.
Nivolumab and Ipilimumab (5 mg/kg) Combination for Prostate Cancer: For nivolumab and ipilimumab combination therapy, CD8 low arm, approximately 10 participants will be randomly allocated into 1 of 2 cohorts, using different doses of ipilimumab administered in 6-week cycles. Participants assigned to Prostate Cohort B will receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity. If Prostate Cohort B is determined to have a tolerable safety profile, an additional 10 participants will be enrolled to receive nivolumab 1 mg/kg Q3W and ipilimumab 5 mg/kg Q6W for 2 cycles, then nivolumab maintenance 480 mg Q4W until PD or intolerable toxicity.
|
|---|---|---|---|---|---|
|
Investigations
Alanine Aminotransferase Increased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
8.3%
6/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
3/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Amylase Increased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Aspartate Aminotransferase Increased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
12.5%
9/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
3/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Blood Creatinine Increased
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.9%
10/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
5.6%
4/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Blood Lactate Dehydrogenase Increased
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Blood Thyroid Stimulating Hormone Increased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
5.6%
4/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Lipase increased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
15.3%
11/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Low Density Lipoprotein Increased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
100.0%
1/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.9%
5/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Pancreatic Enzymes Increased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.3%
2/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Sars-Cov-2 Test Positive
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Thyroid Function Test Abnormal
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Thyroxine Decreased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Transaminases increased
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Tri-Iodothyronine Decreased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Troponin I Increased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Troponin Increased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Weight Decreased
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.9%
5/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
26.7%
4/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
Weight Increased
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Investigations
White Blood Cell Count Decreased
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Abdominal Pain
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
16.7%
12/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.3%
2/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Constipation
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
18.1%
13/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
26.7%
4/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
29.2%
21/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
3/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
4.2%
3/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Dysphagia
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.3%
2/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
25.0%
18/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
33.3%
5/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Stomatitis
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
8.3%
6/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
100.0%
1/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Gastrointestinal disorders
Vomiting
|
28.6%
2/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
18.1%
13/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
26.7%
4/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
28.6%
2/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
18.1%
13/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
40.0%
2/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.3%
2/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
9.7%
7/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
40.0%
2/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.3%
2/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.3%
2/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
5.6%
4/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
40.0%
2/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
3/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
11.1%
8/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
40.0%
2/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.3%
2/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.3%
2/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.3%
2/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
General disorders
Asthenia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
General disorders
Chills
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
8.3%
6/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
General disorders
Facial pain
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
General disorders
Fatigue
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
50.0%
36/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
100.0%
1/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
60.0%
3/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
26.7%
4/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
General disorders
Influenza like illness
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
5.6%
4/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
General disorders
Oedema peripheral
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
5.6%
4/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
100.0%
1/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
General disorders
Pyrexia
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
9.7%
7/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.9%
10/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
15.3%
11/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
3/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
5.6%
4/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
8.3%
6/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
16.7%
12/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
28.6%
2/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
5.6%
4/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.3%
2/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia Rheumatica
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Skin and subcutaneous tissue disorders
Dermatitis Bullous
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
16.7%
12/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.8%
15/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
100.0%
1/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
40.0%
2/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
26.7%
4/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
8.3%
6/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Body tinea
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Campylobacter Colitis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Coronavirus infection
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Covid-19
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Hordeolum
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Oral Candidiasis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Otitis Externa
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Penile Infection
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
4.2%
3/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Skin Infection
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
5.6%
4/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Infections and infestations
Urinary Tract Infection
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
4.2%
3/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Endocrine disorders
Adrenal Insufficiency
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
4.2%
3/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.3%
2/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Endocrine disorders
Hyperthyroidism
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
4.2%
3/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.3%
2/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Endocrine disorders
Hypophysitis
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Endocrine disorders
Hypothyroidism
|
28.6%
2/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
11.1%
8/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
3/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Endocrine disorders
Thyroiditis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Acute Respiratory Distress Syndrome
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
18.1%
13/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
3/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
25.0%
18/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
3/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
5.6%
4/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
4.2%
3/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Nervous system disorders
Trigeminal neuralgia
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-Airway Cough Syndrome
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Renal and urinary disorders
Acute Kidney Injury
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Renal and urinary disorders
Chronic Kidney Disease
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Renal and urinary disorders
Cystitis Noninfective
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Renal and urinary disorders
Hydronephrosis
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Renal and urinary disorders
Urinary Tract Obstruction
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Blood and lymphatic system disorders
Anaemia
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
19.4%
14/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
40.0%
2/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.3%
2/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
1.4%
1/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
4.2%
3/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.3%
2/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
9.7%
7/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
13.3%
2/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Nervous system disorders
Bell's Palsy
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
8.3%
6/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Nervous system disorders
Headache
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
15.3%
11/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Cardiac disorders
Sinus Node Dysfunction
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer Pain
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Extradural Neoplasm
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
5.6%
4/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Vascular disorders
Embolism Venous
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
9.7%
7/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Vascular disorders
Hypotension
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
4.2%
3/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Vascular disorders
Jugular vein thrombosis
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Vascular disorders
Lymphoedema
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Eye disorders
Eye pain
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Eye disorders
Photophobia
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
2.8%
2/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Eye disorders
Vision Blurred
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
20.0%
1/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
0.00%
0/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
6.7%
1/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
|
Surgical and medical procedures
Abscess drainage
|
14.3%
1/7 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/72 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/1 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/5 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
0.00%
0/15 • From initiation of study drug until death due to any cause, up to 43 months. All adverse events (AEs), regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Serious Adverse Events (SAEs) that occurred after the end of the AE reporting period (100-days post last dose) and that were considered to be reasonably related to the study drug by the investigator, were also collected.
Investigators recorded AEs during each participant encounter. All AEs, regardless of relationship to study drug, were collected from the time the participant signed informed consent until 100 days after the last dose of study intervention. Prior to initiation of study intervention, only AEs that were related to a protocol mandated intervention (e.g. biopsy), including those that occurred prior to being assigned to a study arm, were collected.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Trial Site and/or Co-Principal Investigators may publish or present Study Data and other results of the Study from the Trial Site individually upon the first to occur of: (i) twelve (12) months after conclusion, abandonment, or termination of the Study at all Affiliated Research Institutions, or (ii) after Parker Institute for Cancer Immunotherapy (PICI) confirms in writing there will not be a multi-site Study publication.
- Publication restrictions are in place
Restriction type: OTHER