Trial Outcomes & Findings for A Study of BGB324 (Bemcentinib) in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer (NCT NCT02424617)
NCT ID: NCT02424617
Last Updated: 2025-02-26
Results Overview
An adverse event (AE) is any untoward medical occurrence in participants, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were defined as AEs that occurred from the first dose of study drug administration up to 28-days post last dose of study drug.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
40 participants
Primary outcome timeframe
First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Results posted on
2025-02-26
Participant Flow
Participant milestones
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of dose limiting toxicities (DLTs), participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating epidermal growth factor receptor (EGFR) mutation who had progressed after receiving prior EGFR tyrosine kinase inhibitor (TKI) or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
8
|
11
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
11
|
13
|
Reasons for withdrawal
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of dose limiting toxicities (DLTs), participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating epidermal growth factor receptor (EGFR) mutation who had progressed after receiving prior EGFR tyrosine kinase inhibitor (TKI) or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
|
Overall Study
Investigator Decision
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
1
|
|
Overall Study
Progressive Disease
|
7
|
6
|
11
|
10
|
|
Overall Study
Other
|
0
|
0
|
0
|
1
|
Baseline Characteristics
A Study of BGB324 (Bemcentinib) in Combination With Erlotinib in Patients With Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
n=8 Participants
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
n=8 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
n=11 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating EGFR mutation who had progressed after receiving prior EGFR TKI or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
n=13 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
63.1 years
STANDARD_DEVIATION 6.15 • n=5 Participants
|
57.9 years
STANDARD_DEVIATION 9.14 • n=7 Participants
|
64.0 years
STANDARD_DEVIATION 8.97 • n=5 Participants
|
64.3 years
STANDARD_DEVIATION 13.24 • n=4 Participants
|
62.7 years
STANDARD_DEVIATION 10.13 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
16 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)Population: The safety analysis population included all participants who received at least 1 dose of bemcentinib or erlotinib.
An adverse event (AE) is any untoward medical occurrence in participants, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs were defined as AEs that occurred from the first dose of study drug administration up to 28-days post last dose of study drug.
Outcome measures
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
n=8 Participants
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
n=8 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
n=11 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating EGFR mutation who had progressed after receiving prior EGFR TKI or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
n=13 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAE)
|
8 Participants
|
8 Participants
|
11 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)Population: The safety analysis population included all participants who received at least 1 dose of bemcentinib or erlotinib.
Laboratory evaluation: assessment of hematology, clinical chemistry, coagulation, and urinalysis. Hematology assessment: full blood count including differential white cell count, hemoglobin, hematocrit and platelets. Clinical chemistry assessment: potassium, calcium, uric acid, electrolytes, blood urea nitrogen, total protein, total bilirubin, alanine aminotransferase, aspartate aminotransferase, creatinine, creatine phosphokinase, alkaline phosphatase, albumin, phosphorus, glucose, magnesium plus amylase and lipase. Coagulation assessment: prothrombin time and/or international normalized ratio, activated partial thromboplastin time. Urinalysis: dipstick measurement of blood, nitrite, glucose, ketones, leukocytes, protein, and pH. Clinical significance was determined based on investigator's decision. In this outcome measure number of participants with clinically significant abnormalities in assessment of hematology, clinical chemistry, coagulation, and urinalysis are reported.
Outcome measures
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
n=8 Participants
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
n=8 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
n=11 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating EGFR mutation who had progressed after receiving prior EGFR TKI or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
n=13 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Hematology Abnormality
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Clinical Chemistry Abnormality
|
4 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Coagulation Abnormality
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Clinically Significant Laboratory Abnormalities
Urinalysis Abnormality
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: End of study visit was 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)Population: The safety analysis population included all participants who received at least 1 dose of bemcentinib or erlotinib. Here, "Overall Number of Participants Analyzed" signifies participants who were evaluable for this outcome measure.
The ECOG performance status was scored on a scale of Grade 0 to 5, where: 0 = Fully active, able to carry on all pre-disease performance without restriction; 1 = Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g. light house work, office work; 2 = Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3 = Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4 = Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair; 5 = Dead. Higher scores indicated worse condition. Number of participants with each ECOG Grade were reported.
Outcome measures
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
n=5 Participants
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
n=7 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
n=9 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating EGFR mutation who had progressed after receiving prior EGFR TKI or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
n=12 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
|---|---|---|---|---|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at End of Study
Grade 0
|
1 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at End of Study
Grade 1
|
2 Participants
|
4 Participants
|
4 Participants
|
10 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at End of Study
Grade 2
|
1 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at End of Study
Grade 3
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at End of Study
Grade 4
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Eastern Cooperative Oncology Group (ECOG) Performance Status at End of Study
Grade 5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Baseline up to end of the study (28 days post last dose; maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)Population: The safety analysis population included all participants who received at least 1 dose of bemcentinib or erlotinib.
Number of participants with clinically significant change from baseline in physical examination, vital signs (including blood pressure, pulse, respiratory rate and oral temperature) and 12-lead triplicate ECG parameters was reported. Clinically significant abnormalities were based on the investigator's decision.
Outcome measures
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
n=8 Participants
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
n=8 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
n=11 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating EGFR mutation who had progressed after receiving prior EGFR TKI or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
n=13 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Change From Baseline in Physical Examination, Vital Signs, and 12- Lead Triplicate Electrocardiogram (ECG) Parameters up to End of Study
Physical Examination
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in Physical Examination, Vital Signs, and 12- Lead Triplicate Electrocardiogram (ECG) Parameters up to End of Study
Vital Signs
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Change From Baseline in Physical Examination, Vital Signs, and 12- Lead Triplicate Electrocardiogram (ECG) Parameters up to End of Study
12- lead Triplicate ECG
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)Population: The safety analysis population included all participants who received at least 1 dose of bemcentinib or erlotinib.
Number of participants with clinically significant abnormalities in echocardiogram and MUGA scan was reported. MUGA scan is used to measure the ejection fraction, which reports how well heart is functioning. Clinically significant abnormalities were based on the investigator's decision.
Outcome measures
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
n=8 Participants
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
n=8 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
n=11 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating EGFR mutation who had progressed after receiving prior EGFR TKI or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
n=13 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
|---|---|---|---|---|
|
Number of Participants With Clinically Significant Abnormalities in Echocardiogram and Multi-gated Acquisition (MUGA) Scan
Echocardiogram
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Clinically Significant Abnormalities in Echocardiogram and Multi-gated Acquisition (MUGA) Scan
MUGA
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Arm A only: Cycle(C)1 Day(D)1: Predose, 2, 4, 6, 8 & 24h post-dose; Arm B only: C1D1 & D2: Predose; Arms A&B: C1D8: Predose, 2, 4, 6, 8 & 24h post-dose: C1D15, C2D1,8 & 15, C3D1: Predose and End of StudyPopulation: The pharmacokinetic(PK)analysis population included those participants in Run-in Cohort and Arm B who received at least 1 dose of bemcentinib,had PK data available and those participants in ArmA, ArmB who received at least 1 dose of bemcentinib and erlotinib, had bemcentinib and erlotinib PK data available. For PK outcome measure, Arm A is divided in two arms based on bemcentinib loading dose. PK analysis was not part of primary or secondary objective for Arm C and hence not analyzed for Arm C.
The AUC is defined as the area under the curve over 24 hours at steady state. The AUC 0- 24 hours using the linear trapezoidal method was summarized using the predicted plasma concentrations at steady state.
Outcome measures
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
n=6 Participants
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
n=4 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
n=4 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating EGFR mutation who had progressed after receiving prior EGFR TKI or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
n=11 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
|---|---|---|---|---|
|
Area Under the Curve (AUC) Over 24 Hours at Steady State of Bemcentinib
|
6590 nanogram*hours per milliliter
Standard Deviation 3800
|
8200 nanogram*hours per milliliter
Standard Deviation 5460
|
5710 nanogram*hours per milliliter
Standard Deviation 1950
|
5810 nanogram*hours per milliliter
Standard Deviation 1900
|
SECONDARY outcome
Timeframe: Arm A only: Cycle(C)1 Day(D)1: Predose, 2, 4, 6, 8 & 24h post-dose; Arm B only: C1D1 & D2: Predose; Arms A&B: C1D8: Predose, 2, 4, 6, 8 & 24h post-dose: C1D15, C2D1,8 & 15, C3D1: Predose and End of StudyPopulation: The PK analysis population included those participants in the Run-in Cohort and Arm B who received at least 1 dose of bemcentinib and had PK data available and those participants in Arm A who received at least 1 dose of bemcentinib and erlotinib and had bemcentinib and erlotinib PK data available. For PK outcome measure, Arm A is divided in two arms based on bemcentinib loading dose. PK analysis was not part of primary or secondary objective for Arm C and hence not analyzed for Arm C.
Cmax was defined as the observed maximum plasma concentration after single dose administration. Cmax was summarized using the predicted plasma concentrations at steady state.
Outcome measures
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
n=6 Participants
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
n=4 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
n=4 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating EGFR mutation who had progressed after receiving prior EGFR TKI or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
n=11 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
|---|---|---|---|---|
|
Maximum Observed Plasma Concentration (Cmax) of Bemcentinib
|
282 nanogram per milliliter
Standard Deviation 161
|
349 nanogram per milliliter
Standard Deviation 229
|
245 nanogram per milliliter
Standard Deviation 77.9
|
249 nanogram per milliliter
Standard Deviation 81.9
|
SECONDARY outcome
Timeframe: Arm A only: Cycle(C)1 Day(D)1: Predose, 2, 4, 6, 8 & 24h post-dose; Arm B only: C1D1 & D2: Predose; Arms A&B: C1D8: Predose, 2, 4, 6, 8 & 24h post-dose: C1D15, C2D1,8 & 15, C3D1: Predose and End of StudyPopulation: The PK analysis population included those participants in the Run-in Cohort and Arm B who received at least 1 dose of bemcentinib and had PK data available and those participants in Arm A who received at least 1 dose of bemcentinib and erlotinib and had bemcentinib and erlotinib PK data available. For PK outcome measure, Arm A is divided in two arms based on bemcentinib loading dose. PK analysis was not part of primary or secondary objective for Arm C and hence not analyzed for Arm C.
The Tmax defined as the time taken to reach Cmax. The Tmax was summarized using the predicted plasma concentrations at steady state.
Outcome measures
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
n=6 Participants
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
n=4 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
n=4 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating EGFR mutation who had progressed after receiving prior EGFR TKI or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
n=11 Participants
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
|---|---|---|---|---|
|
Time to Reach Maximum Plasma Concentration (Tmax) of Bemcentinib
|
6.5 hours
Interval 6.0 to 8.0
|
8 hours
Interval 6.0 to 11.0
|
7 hours
Interval 7.0 to 7.0
|
7 hours
Interval 4.0 to 11.0
|
SECONDARY outcome
Timeframe: At Day 8 (in Cycle 1): pre-dose, 2, 4, 6, 8 and 24 hours post-dose (cycle length=21 days)Population: Analysis population included those participants who received erlotinib in Arm A and Arm B and had PK data available are pooled under one reporting group (pooled erlotinib). PK analysis was not part of primary or secondary objective for Arm C, hence not analyzed. Here, 'Number of Participants Analyzed' = participants evaluable for this outcome measure.
The AUC 0-24 is defined as the area under the curve over 24 hours at steady state. The AUC 0- 24 hours using the linear trapezoidal method was summarized using the predicted plasma concentrations at steady state.
Outcome measures
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
n=3 Participants
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating EGFR mutation who had progressed after receiving prior EGFR TKI or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
|---|---|---|---|---|
|
AUC Over 24 Hours at Steady State of Erlotinib
|
40432.333 nanogram*hours per milliliter
Standard Deviation 9877.386
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1 and 8 (in Cycle 1): pre-dose, 2, 4, 6, 8 and 24 hours post-dose (cycle length=21 days)Population: Analysis population included those participants who received erlotinib in Arm A and Arm B and had PK data available are pooled under one reporting group (pooled erlotinib). PK analysis was not part of primary or secondary objective for Arm C, hence not analyzed. Here, 'Number analyzed' = participants evaluable at specific timepoints.
Cmax was defined as the observed maximum plasma concentration after single dose administration. Cmax was summarized using the predicted plasma concentrations at steady state.
Outcome measures
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
n=14 Participants
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating EGFR mutation who had progressed after receiving prior EGFR TKI or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
|---|---|---|---|---|
|
Cmax of Erlotinib
Cycle 1 Day 1
|
1840.286 nanogram per milliliter
Standard Deviation 715.704
|
—
|
—
|
—
|
|
Cmax of Erlotinib
Cycle 1 Day 8
|
2263.750 nanogram per milliliter
Standard Deviation 711.310
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: At Day 1 and 8 (in Cycle 1): pre-dose, 2, 4, 6, 8 and 24 hours post-dose (cycle length=21 days)Population: Data was not available to report time taken to reach Cmax as none of the participants were considered evaluable for this derived PK parameter, due to insufficient dosing records for erlotinib.
The Tmax defined as the time taken to reach Cmax. The Tmax was summarized using the predicted plasma concentrations at steady state.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)Population: The safety analysis population included all participants who received at least 1 dose of bemcentinib or erlotinib. This outcome measure was planned to be analyzed for only Arm A.
DLTs included any non-hematological toxicity ≥ Grade 3 except Grade 3 nausea, vomiting or diarrhea that resolved within 72 hours with optimal therapy: Grade 4 thrombocytopenia or Grade 3 thrombocytopenia with bleeding. Grade 4 neutropenia persisting for ≥ 5 days or Grade 3 or 4 febrile neutropenia. Treatment discontinuation or dose reduction for greater than (\>) 72 hours during the first cycle as a result of treatment-related toxicity. DLTs were evaluated using National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE) Version 4.03. Number of participants that reported DLTs were reported in this outcome measure.
Outcome measures
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
n=8 Participants
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating EGFR mutation who had progressed after receiving prior EGFR TKI or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
|---|---|---|---|---|
|
Dose Limiting Toxicity (DLT) Assessment
|
2 Participants
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: First dose of bemcentinib to first radiological progression (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)Population: The efficacy analysis population included all participants who received ≥ 1 cycle of bemcentinib and underwent a post-treatment assessment of response. Here, 'Overall Number of Participants Analyzed' signifies participants evaluable for this outcome measure. This outcome measure was planned to be analyzed for only Arm C.
TTP was calculated as the duration from the date of first administration of bemcentinib to the date of radiological progression of disease first observed, according to the overall response evaluation (progressive disease, measurement proven or progressive disease, symptomatic deterioration). If a participant died without any radiological assessment, the progressive disease date was date of death. Progression was assessed using the Response evaluation criteria in solid tumors (RECIST) version 1.1 criteria.
Outcome measures
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
n=9 Participants
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating EGFR mutation who had progressed after receiving prior EGFR TKI or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
|---|---|---|---|---|
|
Time To Progression (TTP)
|
8.2 Months
Interval 2.8 to 30.7
|
—
|
—
|
—
|
Adverse Events
Phase 1- Run in Arm (Bemcentinib Monotherapy)
Serious events: 2 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase 1- Arm A (Bemcentinib + Erlotinib)
Serious events: 3 serious events
Other events: 8 other events
Deaths: 0 deaths
Phase 2- Arm B (Bemcentinib + Erlotinib)
Serious events: 2 serious events
Other events: 11 other events
Deaths: 0 deaths
Phase 2- Arm C (Bemcentinib + Erlotinib)
Serious events: 5 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
n=8 participants at risk
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
n=8 participants at risk
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
n=11 participants at risk
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating EGFR mutation who had progressed after receiving prior EGFR TKI or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
n=13 participants at risk
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Cerebellar ischaemia
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Vascular disorders
Embolism
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
Other adverse events
| Measure |
Phase 1- Run in Arm (Bemcentinib Monotherapy)
n=8 participants at risk
Participants received bemcentinib at a loading dose of 600 mg on Days 1 and 2 of Cycle 1, followed by 200 mg daily thereafter.
|
Phase 1- Arm A (Bemcentinib + Erlotinib)
n=8 participants at risk
Participants received 150 mg of erlotinib daily along with bemcentinib, starting with a loading dose of 600 mg over 2 days (Days 1 and 2), followed by a daily dose of 200 mg in 21-day treatment cycles. However, following the report of DLTs, participants received daily loading dose of bemcentinib 400 mg on Days 1, 2 and 3 of Cycle 1 followed by a maximum daily maintenance dose of 200 mg thereafter. Hence, some participants received 600 mg and some received 400 mg of bemcentinib as loading dose.
|
Phase 2- Arm B (Bemcentinib + Erlotinib)
n=11 participants at risk
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with an activating EGFR mutation who had progressed after receiving prior EGFR TKI or who had progressed on osimertinib.
|
Phase 2- Arm C (Bemcentinib + Erlotinib)
n=13 participants at risk
Participants received 150 mg of erlotinib daily along with bemcentinib 400 mg on Days 1, 2, and 3 as loading dose and bemcentinib 200 mg as daily maintenance dose for the 21-day cycle with activating EGFR mutation ≥ 12 weeks of erlotinib without disease progression at the time of first dose of bemcentinib, with erlotinib related toxicities well-controlled.
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
50.0%
4/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
100.0%
8/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
72.7%
8/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
92.3%
12/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Nausea
|
50.0%
4/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
87.5%
7/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
45.5%
5/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
69.2%
9/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
50.0%
4/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
63.6%
7/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
38.5%
5/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
37.5%
3/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
30.8%
4/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Dyspepsia
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
18.2%
2/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Glossodynia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Investigations
Electrocardiogram QT prolonged
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
54.5%
6/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
46.2%
6/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
18.2%
2/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
23.1%
3/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
27.3%
3/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Investigations
Blood creatinine increased
|
37.5%
3/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Investigations
Weight decreased
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
18.2%
2/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Investigations
Amylase increased
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Investigations
Blood alkaline phosphatase increased
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Investigations
Blood bicarbonate decreased
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Investigations
Lipase increased
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
General disorders
Fatigue
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
37.5%
3/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
36.4%
4/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
53.8%
7/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
General disorders
Pain
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
General disorders
Early satiety
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
General disorders
Impaired healing
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
General disorders
Temperature intolerance
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
18.2%
2/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
30.8%
4/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
27.3%
3/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
30.8%
4/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Neuropathy peripheral
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Balance disorder
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Headache
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
18.2%
2/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
23.1%
3/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Mental impairment
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
37.5%
3/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
18.2%
2/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
23.1%
3/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
18.2%
2/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
38.5%
5/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
23.1%
3/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Rash
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
27.3%
3/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Nail disorder
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Skin discolouration
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
18.2%
2/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
37.5%
3/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
18.2%
2/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
38.5%
5/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Metabolism and nutrition disorders
Hypochloraemia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
23.1%
3/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Musculoskeletal and connective tissue disorders
Muscle fatigue
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
23.1%
3/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
23.1%
3/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Infections and infestations
Paronychia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
23.1%
3/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Psychiatric disorders
Insomnia
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Renal and urinary disorders
Proteinuria
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
37.5%
3/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
23.1%
3/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Vascular disorders
Hypertension
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
23.1%
3/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Vascular disorders
Hypotension
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
18.2%
2/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Cardiac disorders
Supraventricular tachycardia
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Eye disorders
Conjunctival haemorrhage
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
23.1%
3/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Constipation
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
18.2%
2/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Dysphagia
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Gingival inflammation
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Lip ulceration
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Odynophagia
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Oral pain
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Gastrointestinal disorders
Retching
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
General disorders
Oedema peripheral
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
General disorders
Non-cardiac chest pain
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
General disorders
Asthenia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
General disorders
Chest pain
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
General disorders
Pyrexia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
General disorders
Chills
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
General disorders
Inflammation
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
18.2%
2/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
46.2%
6/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
50.0%
4/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
23.1%
3/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
18.2%
2/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Investigations
Blood parathyroid hormone increased
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Investigations
Breath sounds abnormal
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Investigations
Protein urine
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Hair texture abnormal
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Palmar-plantar erythrodysaesthesia syndrome
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Dementia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Faecal incontinence
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Migraine
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Radiculitis
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Metabolism and nutrition disorders
Vitamin B12 deficiency
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
37.5%
3/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
18.2%
2/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
18.2%
2/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Infections and infestations
Urinary tract infection
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Infections and infestations
Corona virus infection
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Infections and infestations
Influenza
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Infections and infestations
Lung infection
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Psychiatric disorders
Anxiety
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Psychiatric disorders
Bruxism
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Psychiatric disorders
Depression
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Psychiatric disorders
Dysthymic disorder
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Psychiatric disorders
Irritability
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Eye disorders
Vision blurred
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
23.1%
3/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Eye disorders
Cataract
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
23.1%
3/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Eye disorders
Eye swelling
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Eye disorders
Cataract nuclear
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Eye disorders
Dry eye
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Eye disorders
Eyelash thickening
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Eye disorders
Lacrimation increased
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Blood and lymphatic system disorders
Anaemia
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
25.0%
2/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Blood and lymphatic system disorders
Haemorrhagic diathesis
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Injury, poisoning and procedural complications
Pulmonary radiation injury
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Injury, poisoning and procedural complications
Wound
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
15.4%
2/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Renal and urinary disorders
Renal cyst
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Cardiac disorders
Sinus tachycardia
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Cardiac disorders
Cardiac tamponade
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Cardiac disorders
Palpitations
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of eye
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Infections and infestations
Bacterial sepsis
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Cerebellar ischaemia
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Psychiatric disorders
Mental status changes
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
12.5%
1/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
7.7%
1/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
|
Vascular disorders
Embolism
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/8 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
9.1%
1/11 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
0.00%
0/13 • First dose of study drug to 28 days post last dose (maximum study treatment exposure was 1554 days; maximum follow-up = 1582 days)
Same event may appear as both SAE and non-SAE but are distinct events. An event may be categorized as serious in 1 participant and non-serious in another, or a participant may have experienced both SAE and non-SAE. Adverse events were collected based on intervention (dose group) participants were initially assigned to receive, irrespective of loading or maintenance dose de-escalation if it occurred.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place