Trial Outcomes & Findings for A Phase II Open Label Study of BMS-582664 in Locally Advanced or Metastatic Hepatocellular Cancer (NCT NCT00355238)
NCT ID: NCT00355238
Last Updated: 2023-12-01
Results Overview
The percent of participants who have not progressed or died prior to 6 months from the date of their first dose. Participants who have neither progressed nor died but had their last tumor assessment prior to 6 months will not be categorized as progression free and will not be included. Tumor response was measured by the IRRC using mWHO criteria. Progression is defined as a 25% or more increase in the sum of all index lesion areas taking as reference the smallest sum recorded at or following baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
137 participants
Primary outcome timeframe
From first dose up to approximately 6 months after first dose
Results posted on
2023-12-01
Participant Flow
Cohort D data collection is not in scope of the planned primary and secondary endpoints per protocol amendment 07. Participants who are randomized into the doxorubicin arm and cross-over to brivanib prior to or after this amendment will not be included as treated participants in Arm A, B, or C.
Participant milestones
| Measure |
Group A (Brivanib 800 mg QD)
Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD).
|
Group B (Brivanib 800 mg QD)
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD).
|
Group C (400 mg BID)
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID).
|
Cohort D: Doxorubicin
All participants who received at least 1 dose of doxorubicin prior to Protocol Amendment 7. Participants treated with doxorubicin from the original protocol were allowed to cross-over to recieve brivanib alaninate after unequivocal disease progression (no cross-over was allowed for toxicity alone) providing they still met the eligibility criteria and had recovered from doxorubicin toxicities.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
55
|
46
|
22
|
14
|
|
Overall Study
Crossed Over From Doxorubicin to Recieve Brivanib Alaninate
|
0
|
0
|
0
|
6
|
|
Overall Study
COMPLETED
|
0
|
0
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
55
|
46
|
22
|
14
|
Reasons for withdrawal
| Measure |
Group A (Brivanib 800 mg QD)
Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD).
|
Group B (Brivanib 800 mg QD)
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD).
|
Group C (400 mg BID)
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID).
|
Cohort D: Doxorubicin
All participants who received at least 1 dose of doxorubicin prior to Protocol Amendment 7. Participants treated with doxorubicin from the original protocol were allowed to cross-over to recieve brivanib alaninate after unequivocal disease progression (no cross-over was allowed for toxicity alone) providing they still met the eligibility criteria and had recovered from doxorubicin toxicities.
|
|---|---|---|---|---|
|
Overall Study
Adverse event unrelated to study drug
|
2
|
2
|
0
|
1
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
|
Overall Study
Disease progression
|
37
|
36
|
16
|
11
|
|
Overall Study
Study drug toxicity
|
11
|
7
|
5
|
2
|
|
Overall Study
Participant withdrew consent
|
3
|
1
|
0
|
0
|
|
Overall Study
Participant request to discontinue study treatment
|
1
|
0
|
1
|
0
|
Baseline Characteristics
A Phase II Open Label Study of BMS-582664 in Locally Advanced or Metastatic Hepatocellular Cancer
Baseline characteristics by cohort
| Measure |
Group A (Brivanib 800 mg QD)
n=55 Participants
Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD).
|
Group B (Brivanib 800 mg QD)
n=46 Participants
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD).
|
Group C (400 mg BID)
n=22 Participants
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID).
|
Cohort D: Doxorubicin
n=14 Participants
All participants who received at least 1 dose of doxorubicin prior to Protocol Amendment 7. Participants treated with doxorubicin from the original protocol were allowed to cross-over to recieve brivanib alaninate after unequivocal disease progression (no cross-over was allowed for toxicity alone) providing they still met the eligibility criteria and had recovered from doxorubicin toxicities.
|
Total
n=137 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Customized
< 65
|
41 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
97 Participants
n=21 Participants
|
|
Age, Customized
>= 65
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
40 Participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
114 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian Other
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Black/ African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Chinese
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Korean
|
18 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
63 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Malaysian
|
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/Ethnicity, Customized
White
|
18 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
39 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/ Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From first dose up to approximately 6 months after first dosePopulation: All treated participants with no prior systemic therapy (Pre-specified in Group A participants only).
The percent of participants who have not progressed or died prior to 6 months from the date of their first dose. Participants who have neither progressed nor died but had their last tumor assessment prior to 6 months will not be categorized as progression free and will not be included. Tumor response was measured by the IRRC using mWHO criteria. Progression is defined as a 25% or more increase in the sum of all index lesion areas taking as reference the smallest sum recorded at or following baseline.
Outcome measures
| Measure |
Group A (Brivanib 800 mg QD)
n=55 Participants
Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD).
|
Group B (Brivanib 800 mg QD)
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD).
|
Group C (400 mg BID)
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID).
|
|---|---|---|---|
|
Progression Free Survival (PFS) Rate at 6 Months Per Independent Response Review Committee (IRRC) in Cohort A
|
22.4 Percent of participants
Interval 10.9 to 33.9
|
—
|
—
|
PRIMARY outcome
Timeframe: From first dose up to 30 days post last dose (up to approximately 34 months)Population: Pre-specified for all treated participants in group A, B, and C only
An Adverse Event (AE) is defined as any new untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
Group A (Brivanib 800 mg QD)
n=55 Participants
Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD).
|
Group B (Brivanib 800 mg QD)
n=46 Participants
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD).
|
Group C (400 mg BID)
n=22 Participants
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID).
|
|---|---|---|---|
|
The Number of Participants Experiencing Adverse Events (AEs)
|
54 Participants
|
46 Participants
|
22 Participants
|
SECONDARY outcome
Timeframe: From first dose to the date of the first documented response (up to approximately 34 months)Population: Pre-specified for all treated participants in group A, B, and C only
The percent of participants whose best overall response is a partial response (PR) or complete response (CR). Tumor measurements by CT/ MRI of the chest, abdomen and pelvis will be obtained at pre-treatment (within 28 days prior to the start of treatment) and every 6 weeks. Complete Response (CR): Disappearance of all known disease. Must be confirmed 4 or more weeks later. Partial Response (PR): A 50% or more decrease in the sum of all index lesion areas compared to the baseline sum and no unequivocal progression of existing non-index lesions. In addition, there can be no appearance of new lesions. Must be confirmed 4 or more weeks later.
Outcome measures
| Measure |
Group A (Brivanib 800 mg QD)
n=55 Participants
Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD).
|
Group B (Brivanib 800 mg QD)
n=46 Participants
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD).
|
Group C (400 mg BID)
n=22 Participants
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID).
|
|---|---|---|---|
|
Tumor Response Rate Per Independent Response Review Committee (IRRC)
|
7.3 Percent of participants
Interval 2.0 to 17.6
|
4.3 Percent of participants
Interval 0.5 to 14.8
|
0.0 Percent of participants
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: From first dose to the date of the first documented response (up to approximately 34 months)Population: Pre-specified for all treated participants in group A, B, and C only
The percent of participants whose best response is a partial response (PR), complete response (CR) or stable disease (SD). Complete Response (CR): Disappearance of all known disease. Must be confirmed 4 or more weeks later. Partial Response (PR): A 50% or more decrease in the sum of all index lesion areas compared to the baseline sum and no unequivocal progression of existing non-index lesions. In addition, there can be no appearance of new lesions. Must be confirmed 4 or more weeks later. Stable Disease (SD): A decrease of 50% or more or an increase of 25% or more in the sum of all index lesion areas compared to baseline cannot be established. There can be no appearance of new lesions. Documentation must occur 6 weeks (42 days) or more from the baseline determination.
Outcome measures
| Measure |
Group A (Brivanib 800 mg QD)
n=55 Participants
Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD).
|
Group B (Brivanib 800 mg QD)
n=46 Participants
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD).
|
Group C (400 mg BID)
n=22 Participants
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID).
|
|---|---|---|---|
|
Disease Control Rate Per Independent Response Review Committee (IRRC)
|
50.9 Percent of participants
Interval 37.1 to 64.6
|
45.7 Percent of participants
Interval 30.9 to 61.0
|
54.5 Percent of participants
Interval 32.2 to 75.6
|
SECONDARY outcome
Timeframe: From first dose to the date of death (up to approximately 34 months)Population: Pre-specified for all treated participants in group A only
The time (in months) from first dosing until the date of death. For those participants who have not died, survival duration will be censored at the last date the participant was known to be alive.
Outcome measures
| Measure |
Group A (Brivanib 800 mg QD)
n=55 Participants
Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD).
|
Group B (Brivanib 800 mg QD)
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD).
|
Group C (400 mg BID)
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID).
|
|---|---|---|---|
|
Overall Survival for Participants With No Prior Systemic Therapy
|
9.95 Months
Interval 6.77 to 15.21
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose to the date of death (up to approximately 34 months)Population: Pre-specified for all treated participants in group B and C only
The time (in months) from first dosing until the date of death. For those participants who have not died, survival duration will be censored at the last date the participant was known to be alive.
Outcome measures
| Measure |
Group A (Brivanib 800 mg QD)
n=46 Participants
Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD).
|
Group B (Brivanib 800 mg QD)
n=22 Participants
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD).
|
Group C (400 mg BID)
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID).
|
|---|---|---|---|
|
Overall Survival for Participants With One Prior Angiogenesis Inhibitor Therapy
|
9.79 Months
Interval 5.52 to 13.17
|
8.25 Months
Interval 6.83 to
Insufficient number of events
|
—
|
SECONDARY outcome
Timeframe: From first dose to the date of the first documented progression (up to approximately 34 months)Population: Pre-specified for all treated participants in group A, B, and C only
The time (in months) from first dosing date to the date of progression per IRRC. Participants who die without a reported prior progression will be considered to have progressed on their date of death (as found in the BMS clinical database). Participants who did not progress or die will be censored on the date of their last tumor assessment. Participants who have only baseline tumor assessment will be censored on the first dosing date. Progression is defined as a 25% or more increase in the sum of all index lesion areas taking as reference the smallest sum recorded at or following baseline.
Outcome measures
| Measure |
Group A (Brivanib 800 mg QD)
n=55 Participants
Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD).
|
Group B (Brivanib 800 mg QD)
n=46 Participants
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD).
|
Group C (400 mg BID)
n=22 Participants
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID).
|
|---|---|---|---|
|
Progression Free Survival (PFS) Per Independent Response Review Committee (IRRC)
|
2.69 Months
Interval 1.45 to 2.96
|
2.0 Months
Interval 1.41 to 3.91
|
2.96 Months
Interval 1.38 to 5.55
|
SECONDARY outcome
Timeframe: From first dose to the date of the first documented response (up to approximately 34 months)Population: Pre-specified for all treated participants in group A, B, and C only whose best response is either PR or CR
The time from the first dose of study therapy until measurement criteria are first met for Partial response (PR) or complete response (CR), whichever is recorded first. Complete Response (CR): Disappearance of all known disease. Must be confirmed 4 or more weeks later. Partial Response (PR): A 50% or more decrease in the sum of all index lesion areas compared to the baseline sum and no unequivocal progression of existing non-index lesions. In addition, there can be no appearance of new lesions. Must be confirmed 4 or more weeks later.
Outcome measures
| Measure |
Group A (Brivanib 800 mg QD)
n=4 Participants
Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD).
|
Group B (Brivanib 800 mg QD)
n=2 Participants
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD).
|
Group C (400 mg BID)
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID).
|
|---|---|---|---|
|
Time to Response Per Independent Response Review Committee (IRRC)
|
10.4 Months
Interval 1.4 to 20.7
|
1.4 Months
Interval 1.4 to 1.4
|
—
|
SECONDARY outcome
Timeframe: From first dose to the date of documented progressive disease or death (up to approximately 34 months)Population: Pre-specified for all treated participants in group A, B, and C only whose best response is either PR or CR
Duration of response will be computed as from time measurement criteria are met for PR or CR until the date of documented progressive disease or death. Participants who neither relapse nor die will be censored on the date of their last tumor assessment. Progression is defined as a 25% or more increase in the sum of all index lesion areas taking as reference the smallest sum recorded at or following baseline. Complete Response (CR): Disappearance of all known disease. Must be confirmed 4 or more weeks later. Partial Response (PR): A 50% or more decrease in the sum of all index lesion areas compared to the baseline sum and no unequivocal progression of existing non-index lesions. In addition, there can be no appearance of new lesions. Must be confirmed 4 or more weeks later.
Outcome measures
| Measure |
Group A (Brivanib 800 mg QD)
n=4 Participants
Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD).
|
Group B (Brivanib 800 mg QD)
n=2 Participants
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD).
|
Group C (400 mg BID)
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID).
|
|---|---|---|---|
|
Duration of Response Per Independent Response Review Committee (IRRC)
|
2.9 Months
Interval 1.4 to 20.7
|
4.2 Months
Interval 2.8 to 5.5
|
—
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (up to approximately 33 months)Population: Pre-specified for all treated participants in group A, B, and C only with baseline and end of treatment measurements
FHSI-8 (Functional Assessment of Cancer Therapy, Hepatobiliary, Symptom Index) was used to assess HCC-related symptoms. The FHSI-8 includes eight items representing HCC-related symptoms; each symptom is rated by participants on a scale of from 0 to 4. The FHSI-8 total score ranges in value from 0 to 32, with higher scores representing fewer symptoms and lower scores representing more symptoms.
Outcome measures
| Measure |
Group A (Brivanib 800 mg QD)
n=38 Participants
Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD).
|
Group B (Brivanib 800 mg QD)
n=35 Participants
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD).
|
Group C (400 mg BID)
n=18 Participants
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID).
|
|---|---|---|---|
|
Change From Baseline to End of Treatment in FHSI-8 Total Score
|
-4.01 Change from baseline in FSHI-8 score
Standard Deviation 8.37
|
-2.40 Change from baseline in FSHI-8 score
Standard Deviation 4.72
|
-1.06 Change from baseline in FSHI-8 score
Standard Deviation 6.98
|
Adverse Events
Group A (Brivanib 800 mg QD)
Serious events: 24 serious events
Other events: 54 other events
Deaths: 39 deaths
Group B (Brivanib 800 mg QD)
Serious events: 17 serious events
Other events: 45 other events
Deaths: 37 deaths
Group C (400 mg BID)
Serious events: 5 serious events
Other events: 22 other events
Deaths: 13 deaths
Cohort D: Doxorubicin
Serious events: 5 serious events
Other events: 14 other events
Deaths: 4 deaths
Doxorubicin Cross-Over Participants
Serious events: 5 serious events
Other events: 6 other events
Deaths: 3 deaths
Serious adverse events
| Measure |
Group A (Brivanib 800 mg QD)
n=55 participants at risk
Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD).
|
Group B (Brivanib 800 mg QD)
n=46 participants at risk
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD).
|
Group C (400 mg BID)
n=22 participants at risk
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID).
|
Cohort D: Doxorubicin
n=14 participants at risk
All participants who received at least 1 dose of doxorubicin prior to Protocol Amendment 7. Participants treated with doxorubicin from the original protocol were allowed to cross-over to recieve brivanib alaninate after unequivocal disease progression (no cross-over was allowed for toxicity alone) providing they still met the eligibility criteria and had recovered from doxorubicin toxicities.
|
Doxorubicin Cross-Over Participants
n=6 participants at risk
Participants who were randomized into the doxorubicin arm, prior to Amendment 7, and crossed-over to brivanib alaninate after disease progression (not failure of doxorubicin therapy due to toxicity alone), provided that they progressed either during doxorubicin therapy or after doxorubicin and no other therapy for HCC had been subsequently administered.
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Blood and lymphatic system disorders
Polycythaemia
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Cardiac disorders
Myocardial Ischaemia
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Endocrine disorders
Hypothyroidism
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Abdominal Pain
|
5.5%
3/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Ascites
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.3%
2/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Mesenteric Vein Thrombosis
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.3%
2/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Oesophageal Varices Haemorrhage
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Pancreatitis
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Stomatitis
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
General disorders
Asthenia
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
General disorders
Fatigue
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
General disorders
Gait Disturbance
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
General disorders
General Physical Health Deterioration
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
General disorders
Mucosal Inflammation
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
General disorders
Oedema
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
General disorders
Oedema Peripheral
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Hepatobiliary disorders
Cholecystitis Acute
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Hepatobiliary disorders
Gallbladder Disorder
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Hepatobiliary disorders
Hepatic Failure
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
5.5%
3/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Hepatobiliary disorders
Jaundice
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Hepatobiliary disorders
Jaundice Hepatocellular
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Infections and infestations
Biliary Tract Infection
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Infections and infestations
Enterocolitis Infectious
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Infections and infestations
Peritoneal Infection
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Infections and infestations
Pneumonia
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Infections and infestations
Salmonella Bacteraemia
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Infections and infestations
Subcutaneous Abscess
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Ammonia Increased
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Blood Creatinine Increased
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Haemoglobin Decreased
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
International Normalised Ratio Increased
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
14.3%
2/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Platelet Count Decreased
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
5.5%
3/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases To Central Nervous System
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastatic Pain
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm Malignant
|
5.5%
3/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Nervous system disorders
Convulsion
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Nervous system disorders
Encephalopathy
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Nervous system disorders
Hepatic Encephalopathy
|
5.5%
3/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
33.3%
2/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Nervous system disorders
Lethargy
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Psychiatric disorders
Confusional State
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Renal and urinary disorders
Nephropathy Toxic
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Renal and urinary disorders
Proteinuria
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Renal and urinary disorders
Renal Failure Acute
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.3%
2/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Renal and urinary disorders
Renal Infarct
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
5.5%
3/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Vascular disorders
Hypertension
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Vascular disorders
Venous Occlusion
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
Other adverse events
| Measure |
Group A (Brivanib 800 mg QD)
n=55 participants at risk
Participants with no prior systemic therapy receive brivanib (800 mg) daily (QD).
|
Group B (Brivanib 800 mg QD)
n=46 participants at risk
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (800 mg) daily (QD).
|
Group C (400 mg BID)
n=22 participants at risk
Participants with one prior regimen of angiogenesis inhibitor therapy treated with brivanib (400 mg) twice daily (BID).
|
Cohort D: Doxorubicin
n=14 participants at risk
All participants who received at least 1 dose of doxorubicin prior to Protocol Amendment 7. Participants treated with doxorubicin from the original protocol were allowed to cross-over to recieve brivanib alaninate after unequivocal disease progression (no cross-over was allowed for toxicity alone) providing they still met the eligibility criteria and had recovered from doxorubicin toxicities.
|
Doxorubicin Cross-Over Participants
n=6 participants at risk
Participants who were randomized into the doxorubicin arm, prior to Amendment 7, and crossed-over to brivanib alaninate after disease progression (not failure of doxorubicin therapy due to toxicity alone), provided that they progressed either during doxorubicin therapy or after doxorubicin and no other therapy for HCC had been subsequently administered.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Gastritis
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Blood and lymphatic system disorders
Anaemia
|
5.5%
3/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
28.6%
4/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
10.9%
6/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
13.6%
3/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Cardiac disorders
Left Ventricular Hypertrophy
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
14.3%
2/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Cardiac disorders
Myocardial Infarction
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Cardiac disorders
Sinus Bradycardia
|
7.3%
4/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.3%
2/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Cardiac disorders
Supraventricular Extrasystoles
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Cardiac disorders
Ventricular Arrhythmia
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Ear and labyrinth disorders
Vertigo
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Endocrine disorders
Hypothyroidism
|
9.1%
5/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
15.2%
7/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
18.2%
4/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Abdominal Discomfort
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Abdominal Distension
|
7.3%
4/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.3%
2/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Abdominal Pain
|
12.7%
7/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
10.9%
5/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
13.6%
3/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
21.4%
3/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
16.4%
9/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
13.0%
6/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
13.6%
3/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Ascites
|
10.9%
6/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
9.1%
2/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
14.3%
2/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Constipation
|
16.4%
9/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
21.7%
10/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
22.7%
5/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
21.4%
3/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Diarrhoea
|
41.8%
23/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
41.3%
19/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
36.4%
8/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
33.3%
2/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Dry Mouth
|
12.7%
7/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.3%
2/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
5/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
13.0%
6/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
14.3%
2/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Dysphagia
|
5.5%
3/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Faeces Discoloured
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
9.1%
2/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Flatulence
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Nausea
|
38.2%
21/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
41.3%
19/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
31.8%
7/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
28.6%
4/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
33.3%
2/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Oesophagitis
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Stomatitis
|
10.9%
6/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
23.9%
11/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
9.1%
2/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
21.4%
3/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Toothache
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Gastrointestinal disorders
Vomiting
|
29.1%
16/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
30.4%
14/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
31.8%
7/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
General disorders
Asthenia
|
10.9%
6/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
14.3%
2/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
General disorders
Chest Pain
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
General disorders
Fatigue
|
45.5%
25/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
58.7%
27/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
63.6%
14/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
21.4%
3/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
50.0%
3/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
General disorders
Influenza Like Illness
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
General disorders
Mucosal Inflammation
|
5.5%
3/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
21.4%
3/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
General disorders
Oedema
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.3%
2/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
9.1%
2/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
General disorders
Oedema Peripheral
|
20.0%
11/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.3%
2/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
22.7%
5/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
21.4%
3/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
General disorders
Pain
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.3%
2/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
General disorders
Pyrexia
|
5.5%
3/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
8.7%
4/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
10.9%
6/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Infections and infestations
Hordeolum
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Infections and infestations
Infection
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
14.3%
2/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Infections and infestations
Laryngitis
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.3%
2/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Alanine Aminotransferase Increased
|
12.7%
7/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Aspartate Aminotransferase Increased
|
12.7%
7/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
8.7%
4/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Blood Alkaline Phosphatase Increased
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Blood Bilirubin Increased
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Ejection Fraction Decreased
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Electrocardiogram St-T Change
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Gamma-Glutamyltransferase Increased
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Neutrophil Count Decreased
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
9.1%
2/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
21.4%
3/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Platelet Count Decreased
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
8.7%
4/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
13.6%
3/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
21.4%
3/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Qrs Axis Abnormal
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Weight Decreased
|
29.1%
16/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
10.9%
5/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
13.6%
3/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
Weight Increased
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
14.3%
2/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Investigations
White Blood Cell Count Decreased
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
21.4%
3/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
40.0%
22/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
54.3%
25/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
36.4%
8/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
28.6%
4/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Metabolism and nutrition disorders
Dehydration
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
9.1%
2/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
10.9%
6/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
10.9%
5/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
13.6%
3/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
10.9%
6/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
13.0%
6/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
18.2%
4/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
14.3%
2/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
9.1%
2/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.5%
3/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.3%
2/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
9.1%
5/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
15.2%
7/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Musculoskeletal and connective tissue disorders
Pain In Extremity
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.3%
2/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Nervous system disorders
Dizziness
|
20.0%
11/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
13.0%
6/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
18.2%
4/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Nervous system disorders
Dysgeusia
|
5.5%
3/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
9.1%
2/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Nervous system disorders
Headache
|
18.2%
10/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
23.9%
11/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Nervous system disorders
Peripheral Sensory Neuropathy
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.3%
2/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Psychiatric disorders
Anxiety
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Psychiatric disorders
Confusional State
|
5.5%
3/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Psychiatric disorders
Insomnia
|
10.9%
6/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
8.7%
4/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Renal and urinary disorders
Proteinuria
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.3%
2/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
18.2%
4/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.3%
4/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
15.2%
7/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
14.3%
2/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
12.7%
7/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
15.2%
7/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
18.2%
4/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
18.2%
10/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Laryngeal Oedema
|
5.5%
3/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis Allergic
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
57.1%
8/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Skin and subcutaneous tissue disorders
Blister
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
6.5%
3/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.5%
1/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
5.5%
3/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
4.3%
2/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
13.6%
3/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Skin and subcutaneous tissue disorders
Exfoliative Rash
|
1.8%
1/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Skin and subcutaneous tissue disorders
Palmar-Plantar Erythrodysaesthesia Syndrome
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
13.0%
6/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
9.1%
2/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.5%
3/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
2.2%
1/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
9.1%
2/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Skin and subcutaneous tissue disorders
Rash
|
3.6%
2/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
13.0%
6/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
9.1%
2/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Vascular disorders
Hypertension
|
47.3%
26/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
41.3%
19/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
50.0%
11/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
16.7%
1/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
|
Vascular disorders
Venous Occlusion
|
0.00%
0/55 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/46 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/22 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
7.1%
1/14 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
0.00%
0/6 • All-cause mortality was assessed from participants first dose to their study completion (up to approximately 34 months). SAEs and Other AEs were assessed from first dose to 30 days following last dose (up to approximately 34 months)
|
Additional Information
Bristol-Myers Squibb Study Director
Bristol-Myers Squibb
Phone: Please email
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER