Trial Outcomes & Findings for Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC) (NCT NCT03184571)
NCT ID: NCT03184571
Last Updated: 2025-09-25
Results Overview
Objective Response Rate (ORR) includes all participants who have a partial (PR) or complete response (CR) per Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by CT scan or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions,. ORR was defined as the percentage of evaluable patients who had at least 1 confirmed overall response CR or PR according to modified RECIST 1.1 evaluation and definitions of disease response.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
99 participants
Primary outcome timeframe
The disease response is the best improvement or change in a participants cancer burden, as measured from baseline (screening) and then measured again at regular intervals over the whole period of the study, an average of 24 months.
Results posted on
2025-09-25
Participant Flow
Study recruitment was undertaken with 19 sites across 4 countries. The recruitment process began in October 2017 and concluded in October 2022. A sufficient number of volunteers were screened in order to successfully recruit 99 completing patients.
Participants were screened to the inclusion/exclusion criteria of the protocol. The following assessments were performed: Informed Consent, Demographics, Medical History, Pregnancy/FSH, ECOG performance score, Vital signs, Physical examination, Laboratory Safety Testing, ECG, Tumour assessment scans/biopsy, disease assessment and biomarker assessment.
Participant milestones
| Measure |
Cohort A
Cohort A a safety run- in, enrolled participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort B
Cohort B enrolled participants who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy) to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort C
Cohort C enrolled participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
50
|
29
|
20
|
|
Overall Study
COMPLETED
|
14
|
7
|
1
|
|
Overall Study
NOT COMPLETED
|
36
|
22
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bemcentinib (BGB324) in Combination With Pembrolizumab in Patients With Advanced Non-small Cell Lung Cancer (NSCLC)
Baseline characteristics by cohort
| Measure |
Cohort A
n=50 Participants
Cohort A enrols participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort B
n=29 Participants
Cohort B enrols participants who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy) to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort C
n=20 Participants
Cohort C enrols participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Total
n=99 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
64 years
STANDARD_DEVIATION 9.27 • n=5 Participants
|
64.6 years
STANDARD_DEVIATION 9.41 • n=7 Participants
|
64.8 years
STANDARD_DEVIATION 9.33 • n=5 Participants
|
64.4 years
STANDARD_DEVIATION 9.23 • n=4 Participants
|
|
Sex: Female, Male
Female
|
20 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
65 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White
|
47 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
94 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Weight
|
71.92 Kilograms (kg)
STANDARD_DEVIATION 13.296 • n=5 Participants
|
72.61 Kilograms (kg)
STANDARD_DEVIATION 17.146 • n=7 Participants
|
76.00 Kilograms (kg)
STANDARD_DEVIATION 16.096 • n=5 Participants
|
72.95 Kilograms (kg)
STANDARD_DEVIATION 15.003 • n=4 Participants
|
PRIMARY outcome
Timeframe: The disease response is the best improvement or change in a participants cancer burden, as measured from baseline (screening) and then measured again at regular intervals over the whole period of the study, an average of 24 months.Population: This analysis population included all 90 participants who received at least 1 combination dose of bemcentinib and pembrolizumab, had measurable disease at study entry, met the inclusion/exclusion criteria, and had at least 1 on-treatment scan.
Objective Response Rate (ORR) includes all participants who have a partial (PR) or complete response (CR) per Response Evaluation Criteria In Solid Tumors Criteria (RECISTv1.0) for target lesions and assessed by CT scan or MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions,. ORR was defined as the percentage of evaluable patients who had at least 1 confirmed overall response CR or PR according to modified RECIST 1.1 evaluation and definitions of disease response.
Outcome measures
| Measure |
Cohort A
n=44 Participants
Cohort A enrolled participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort B
n=27 Participants
Cohort B enrolled participants who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy) to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort C
n=19 Participants
Cohort C enrolled participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Total Patients
n=90 Participants
This analysis population included all 90 participants who received at least 1 combination dose of bemcentinib and pembrolizumab, had measurable disease at study entry, met the inclusion/exclusion criteria, and had at least 1 on-treatment scan.
|
|---|---|---|---|---|
|
Objective Response Rate (ORR)
|
10 Participants
|
0 Participants
|
0 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: Disease response is assessed every 9 weeks for the first 45 weeks and then every 12 weeks until disease progression (worsens) or study completion, an average of 24 months.Population: This analysis population included all 90 participants who received at least 1 combination dose of bemcentinib and pembrolizumab, had measurable disease at study entry, met the inclusion/exclusion criteria, and had at least 1 on-treatment scan.
Disease Control Rate includes all participants who have a partial or complete response, or who maintain stable disease.
Outcome measures
| Measure |
Cohort A
n=44 Participants
Cohort A enrolled participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort B
n=27 Participants
Cohort B enrolled participants who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy) to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort C
n=19 Participants
Cohort C enrolled participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Total Patients
n=90 Participants
This analysis population included all 90 participants who received at least 1 combination dose of bemcentinib and pembrolizumab, had measurable disease at study entry, met the inclusion/exclusion criteria, and had at least 1 on-treatment scan.
|
|---|---|---|---|---|
|
Disease Control Rate
|
24 Participants
|
12 Participants
|
10 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: Disease response is assessed every 9 weeks for the first 45 weeks and then every 12 weeks until disease progression or study completion, an average of 24 months.Population: This analysis population included all 10 participants with partial (PR) or complete (CR ) response per Response Evaluation Criteria in Solid Tumours Criteria (RECIST v1.0) for target lesions and assessed by CT scan or MRI.
Duration of response includes participants with a partial or complete response and is measured from the date of response until the cancer progresses (worsens).
Outcome measures
| Measure |
Cohort A
n=10 Participants
Cohort A enrolled participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort B
Cohort B enrolled participants who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy) to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort C
Cohort C enrolled participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Total Patients
n=10 Participants
This analysis population included all 90 participants who received at least 1 combination dose of bemcentinib and pembrolizumab, had measurable disease at study entry, met the inclusion/exclusion criteria, and had at least 1 on-treatment scan.
|
|---|---|---|---|---|
|
Duration of Response
|
8.1 months
Interval 3.9 to 25.6
|
—
|
—
|
8.1 months
Interval 3.9 to 25.6
|
SECONDARY outcome
Timeframe: Disease assessments are conducted at screening and then every 9 weeks for the first 45 weeks and then every 12 weeks until disease progression or death, whichever comes first, up to study completion (an average of 24 months)Population: This analysis population included all 90 participants who received at least 1 combination dose of bemcentinib and pembrolizumab, had measurable disease at study entry, met the inclusion/exclusion criteria, and had at least 1 on-treatment scan
PFS is measured from the date of the 1st dose of the 1st cycle until the date of progression (the date on which the progression is initially observed) or the date of death (whichever is earlier).
Outcome measures
| Measure |
Cohort A
n=44 Participants
Cohort A enrolled participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort B
n=27 Participants
Cohort B enrolled participants who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy) to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort C
n=19 Participants
Cohort C enrolled participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Total Patients
n=90 Participants
This analysis population included all 90 participants who received at least 1 combination dose of bemcentinib and pembrolizumab, had measurable disease at study entry, met the inclusion/exclusion criteria, and had at least 1 on-treatment scan.
|
|---|---|---|---|---|
|
Progression-free Survival (PFS)
|
35.7 weeks
Interval 18.0 to 54.1
|
26.1 weeks
Interval 9.6 to 36.0
|
26.0 weeks
Interval 9.7 to 64.4
|
27.1 weeks
Interval 19.0 to 38.0
|
SECONDARY outcome
Timeframe: Survival visits are conducted every 12 weeks after disease progression until death or until study completion (an average of 24 months).Population: This analysis population included all 90 participants who received at least 1 combination dose of bemcentinib and pembrolizumab, had measurable disease at study entry, met the inclusion/exclusion criteria, and had at least 1 on-treatment scan
Time to death is measured from the date of first dose until the date of death or the date the participants is last known to be alive. It includes all participants.
Outcome measures
| Measure |
Cohort A
n=44 Participants
Cohort A enrolled participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort B
n=27 Participants
Cohort B enrolled participants who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy) to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort C
n=19 Participants
Cohort C enrolled participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Total Patients
n=90 Participants
This analysis population included all 90 participants who received at least 1 combination dose of bemcentinib and pembrolizumab, had measurable disease at study entry, met the inclusion/exclusion criteria, and had at least 1 on-treatment scan.
|
|---|---|---|---|---|
|
Overall Survival
|
61.0 weeks
Interval 46.3 to 75.9
|
43.7 weeks
Interval 29.1 to 70.1
|
64.4 weeks
Interval 27.9 to 110.7
|
56.6 weeks
Interval 43.7 to 66.7
|
SECONDARY outcome
Timeframe: Adverse events are collected from the date of consent until up to 120 days after cessation of both treatments, up to 24 months of treatment, followed by an additional 120 days following cessation, up to 27 months total.Population: This analysis population included all 99 enrolled participants who received at least one dose of study treatment (bemcentinib and pembrolizumab).
The number of participants with each adverse event (AE) will be summarized.
Outcome measures
| Measure |
Cohort A
n=50 Participants
Cohort A enrolled participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort B
n=29 Participants
Cohort B enrolled participants who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy) to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort C
n=20 Participants
Cohort C enrolled participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Total Patients
n=99 Participants
This analysis population included all 90 participants who received at least 1 combination dose of bemcentinib and pembrolizumab, had measurable disease at study entry, met the inclusion/exclusion criteria, and had at least 1 on-treatment scan.
|
|---|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
|
49 Participants
|
29 Participants
|
20 Participants
|
98 Participants
|
SECONDARY outcome
Timeframe: Up to 106 weeksPopulation: This analysis population included all 99 enrolled participants who received at least one dose of study treatment (bemcentinib and pembrolizumab).
Cmax defined as the maximum observed concentration. These Cmax results are after the maintenance dose.
Outcome measures
| Measure |
Cohort A
n=50 Participants
Cohort A enrolled participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort B
n=29 Participants
Cohort B enrolled participants who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy) to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort C
n=20 Participants
Cohort C enrolled participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Total Patients
n=99 Participants
This analysis population included all 90 participants who received at least 1 combination dose of bemcentinib and pembrolizumab, had measurable disease at study entry, met the inclusion/exclusion criteria, and had at least 1 on-treatment scan.
|
|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters: Maximum Observed Concentration (Cmax)
|
270 ng/mL
Standard Deviation 165
|
304 ng/mL
Standard Deviation 153
|
244 ng/mL
Standard Deviation 134
|
275 ng/mL
Standard Deviation 156
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 and Day 3 pre-dose, and 2, 4, 6, 8 hours post-dose; Cycle 1 Day 2 , Day 4 ,Day 8 and Day 15 pre-dose; Cycle 2 Day 1, and Cycle 3 Day 1., pre-dose. Each cycle is 21 days in duration.Population: This analysis population included all 99 enrolled participants who received at least one dose of study treatment (bemcentinib and pembrolizumab).
AUC defined as the area under the concentration versus time curve. Measured as AUC 0-24h, area under the concentration versus time curve from time 0 to 24 hours post-dose at steady state following the maintenance dose per cohort.
Outcome measures
| Measure |
Cohort A
n=50 Participants
Cohort A enrolled participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort B
n=29 Participants
Cohort B enrolled participants who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy) to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort C
n=20 Participants
Cohort C enrolled participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Total Patients
n=99 Participants
This analysis population included all 90 participants who received at least 1 combination dose of bemcentinib and pembrolizumab, had measurable disease at study entry, met the inclusion/exclusion criteria, and had at least 1 on-treatment scan.
|
|---|---|---|---|---|
|
PK Parameters: Area Under the Curve (AUC)
|
6250 ng.h/mL
Standard Deviation 3880
|
7090 ng.h/mL
Standard Deviation 3620
|
5640 ng.h/mL
Standard Deviation 3200
|
6370 ng.h/mL
Standard Deviation 3680
|
SECONDARY outcome
Timeframe: Up to 106 weeksPopulation: This analysis population included all 99 enrolled participants who received at least one dose of study treatment (bemcentinib and pembrolizumab).
T½ defined as the elimination half-life. Measured at steady state following the maintenance dose per cohort.
Outcome measures
| Measure |
Cohort A
n=50 Participants
Cohort A enrolled participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort B
n=29 Participants
Cohort B enrolled participants who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy) to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort C
n=20 Participants
Cohort C enrolled participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Total Patients
n=99 Participants
This analysis population included all 90 participants who received at least 1 combination dose of bemcentinib and pembrolizumab, had measurable disease at study entry, met the inclusion/exclusion criteria, and had at least 1 on-treatment scan.
|
|---|---|---|---|---|
|
PK Parameters: Elimination Half-life (T½)
|
181 hours
Standard Deviation 263
|
192 hours
Standard Deviation 195
|
135 hours
Standard Deviation 89.9
|
175 hours
Standard Deviation 218
|
SECONDARY outcome
Timeframe: Up to 106 weeksPopulation: This analysis population included all 99 enrolled participants who received at least one dose of study treatment (bemcentinib and pembrolizumab).
Number of events (Frequency) of clinically significant laboratory (hematology, including coagulation, urinalysis), vital signs (temperature, systolic blood pressure, diastolic blood pressure, heart rate, and respiratory rate), and ECG abnormalities.
Outcome measures
| Measure |
Cohort A
n=99 Participants
Cohort A enrolled participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort B
Cohort B enrolled participants who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy) to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort C
Cohort C enrolled participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Total Patients
This analysis population included all 90 participants who received at least 1 combination dose of bemcentinib and pembrolizumab, had measurable disease at study entry, met the inclusion/exclusion criteria, and had at least 1 on-treatment scan.
|
|---|---|---|---|---|
|
Frequency of Clinical Laboratory, Vital Signs, and Electrocardiogram (ECG) Abnormalities.
Hematological
|
19 events
|
—
|
—
|
—
|
|
Frequency of Clinical Laboratory, Vital Signs, and Electrocardiogram (ECG) Abnormalities.
Clinical Chemistry
|
289 events
|
—
|
—
|
—
|
|
Frequency of Clinical Laboratory, Vital Signs, and Electrocardiogram (ECG) Abnormalities.
Urinalysis
|
0 events
|
—
|
—
|
—
|
|
Frequency of Clinical Laboratory, Vital Signs, and Electrocardiogram (ECG) Abnormalities.
Vital signs
|
0 events
|
—
|
—
|
—
|
|
Frequency of Clinical Laboratory, Vital Signs, and Electrocardiogram (ECG) Abnormalities.
ECG
|
43 events
|
—
|
—
|
—
|
Adverse Events
Cohort A
Serious events: 29 serious events
Other events: 21 other events
Deaths: 41 deaths
Cohort B
Serious events: 11 serious events
Other events: 18 other events
Deaths: 22 deaths
Cohort C
Serious events: 9 serious events
Other events: 11 other events
Deaths: 14 deaths
Serious adverse events
| Measure |
Cohort A
n=50 participants at risk
Cohort A enrols participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort B
n=29 participants at risk
Cohort B enrols participants who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy) to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort C
n=20 participants at risk
Cohort C enrols participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
10.0%
5/50 • Number of events 6 • Up to 106 weeks
|
6.9%
2/29 • Number of events 2 • Up to 106 weeks
|
10.0%
2/20 • Number of events 4 • Up to 106 weeks
|
|
Infections and infestations
Respiratory tract infection
|
4.0%
2/50 • Number of events 2 • Up to 106 weeks
|
3.4%
1/29 • Number of events 1 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Bronchitis
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
3.4%
1/29 • Number of events 1 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
3.4%
1/29 • Number of events 1 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Pneumonia aspiration
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Number of events 1 • Up to 106 weeks
|
|
Infections and infestations
Anal abscess
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Device related infection
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Number of events 1 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Sepsis
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Septic shock
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Number of events 1 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.0%
2/50 • Number of events 2 • Up to 106 weeks
|
3.4%
1/29 • Number of events 2 • Up to 106 weeks
|
5.0%
1/20 • Number of events 1 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Number of events 1 • Up to 106 weeks
|
5.0%
1/20 • Number of events 1 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Number of events 1 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Number of events 1 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
3.4%
1/29 • Number of events 1 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
2/50 • Number of events 2 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Fecalith
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Obstructive pancreatitis
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Number of events 1 • Up to 106 weeks
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
6.0%
3/50 • Number of events 3 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Number of events 1 • Up to 106 weeks
|
|
Hepatobiliary disorders
Hypertransaminasemia
|
4.0%
2/50 • Number of events 2 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Number of events 1 • Up to 106 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Hepatobiliary disorders
Hepatotoxicity
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
6.0%
3/50 • Number of events 12 • Up to 106 weeks
|
3.4%
1/29 • Number of events 1 • Up to 106 weeks
|
5.0%
1/20 • Number of events 2 • Up to 106 weeks
|
|
Investigations
Alanine aminotransferase increased
|
6.0%
3/50 • Number of events 8 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Number of events 1 • Up to 106 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Number of events 1 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
General disorders
Pyrexia
|
4.0%
2/50 • Number of events 2 • Up to 106 weeks
|
3.4%
1/29 • Number of events 1 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
General disorders
Non-cardiac chest pain
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
3.4%
1/29 • Number of events 1 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Number of events 1 • Up to 106 weeks
|
|
Cardiac disorders
Atrial flutter
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Cardiac disorders
Sinus node dysfunction
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
3.4%
1/29 • Number of events 1 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Nervous system disorders
Neuromyelitis optica spectrum disorder
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Number of events 1 • Up to 106 weeks
|
|
Nervous system disorders
Paralysis recurrent laryngeal nerve
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Number of events 1 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Number of events 1 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Number of events 1 • Up to 106 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Vascular disorders
Embolism
|
2.0%
1/50 • Number of events 1 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
Other adverse events
| Measure |
Cohort A
n=50 participants at risk
Cohort A enrols participants who received a maximum of 1 prior line of platinum-containing chemotherapy and no prior immunotherapy of any kind to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort B
n=29 participants at risk
Cohort B enrols participants who received a maximum of one prior line of an anti-PD-(L)1 therapy (monotherapy) to receive bemcentinib (BGB324) in combination with pembrolizumab.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
Cohort C
n=20 participants at risk
Cohort C enrols participants who received a maximum of one prior line of therapy with an anti-PD-(L)1 therapy in combination with a platinum-containing chemotherapy.
Bemcentinib capsules are administered at 400mg for days 1-3, and 200mg thereafter. Pembrolizumab is an IV infusion, administered at a dose of 200mg every 3 weeks.
|
|---|---|---|---|
|
General disorders
Asthenia
|
22.0%
11/50 • Up to 106 weeks
|
24.1%
7/29 • Up to 106 weeks
|
10.0%
2/20 • Up to 106 weeks
|
|
General disorders
Fatigue
|
14.0%
7/50 • Up to 106 weeks
|
27.6%
8/29 • Up to 106 weeks
|
35.0%
7/20 • Up to 106 weeks
|
|
General disorders
Pyrexia
|
10.0%
5/50 • Up to 106 weeks
|
24.1%
7/29 • Up to 106 weeks
|
20.0%
4/20 • Up to 106 weeks
|
|
General disorders
Influenza like illness
|
12.0%
6/50 • Up to 106 weeks
|
6.9%
2/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
General disorders
Oedema peripheral
|
6.0%
3/50 • Up to 106 weeks
|
13.8%
4/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
General disorders
Non-cardiac chest pain
|
10.0%
5/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
General disorders
Peripheral swelling
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
10.0%
2/20 • Up to 106 weeks
|
|
General disorders
General physical health deterioration
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
General disorders
Mucosal inflammation
|
2.0%
1/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
General disorders
Pain
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
General disorders
Chest discomfort
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
General disorders
Chest pain
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
General disorders
Chills
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
General disorders
Device related thrombosis
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
General disorders
Feeling of body temperature change
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
General disorders
Hunger
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
General disorders
Illness
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
General disorders
Malaise
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
General disorders
Suprapubic pain
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
General disorders
Swelling face
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
General disorders
Temperature regulation disorder
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Investigations
Blood creatinine increased
|
22.0%
11/50 • Up to 106 weeks
|
37.9%
11/29 • Up to 106 weeks
|
40.0%
8/20 • Up to 106 weeks
|
|
Investigations
Alanine aminotransferase increased
|
20.0%
10/50 • Up to 106 weeks
|
24.1%
7/29 • Up to 106 weeks
|
20.0%
4/20 • Up to 106 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
22.0%
11/50 • Up to 106 weeks
|
20.7%
6/29 • Up to 106 weeks
|
30.0%
6/20 • Up to 106 weeks
|
|
Investigations
Electrocardiogram QT prolonged
|
12.0%
6/50 • Up to 106 weeks
|
24.1%
7/29 • Up to 106 weeks
|
20.0%
4/20 • Up to 106 weeks
|
|
Investigations
Amylase increased
|
6.0%
3/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
15.0%
3/20 • Up to 106 weeks
|
|
Investigations
Blood alkaline phosphatase increased
|
12.0%
6/50 • Up to 106 weeks
|
6.9%
2/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Investigations
Weight decreased
|
6.0%
3/50 • Up to 106 weeks
|
6.9%
2/29 • Up to 106 weeks
|
15.0%
3/20 • Up to 106 weeks
|
|
Investigations
Gamma-glutamyltransferase increased
|
6.0%
3/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Investigations
Blood cholesterol increased
|
4.0%
2/50 • Up to 106 weeks
|
10.3%
3/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Investigations
Platelet count decreased
|
4.0%
2/50 • Up to 106 weeks
|
6.9%
2/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Investigations
Neutrophil count decreased
|
4.0%
2/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Investigations
Lymphocyte count decreased
|
4.0%
2/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Investigations
White blood cell count decreased
|
4.0%
2/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Investigations
Blood creatine increased
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Investigations
Blood folate decreased
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Investigations
Blood iron decreased
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Investigations
Computerised tomogram abnormal
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Investigations
Cortisol decreased
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Investigations
Ejection fraction decreased
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Investigations
Electrocardiogram abnormal
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Investigations
Urine bilirubin increased
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
40.0%
20/50 • Up to 106 weeks
|
41.4%
12/29 • Up to 106 weeks
|
40.0%
8/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Nausea
|
24.0%
12/50 • Up to 106 weeks
|
24.1%
7/29 • Up to 106 weeks
|
25.0%
5/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Vomiting
|
14.0%
7/50 • Up to 106 weeks
|
20.7%
6/29 • Up to 106 weeks
|
20.0%
4/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Constipation
|
14.0%
7/50 • Up to 106 weeks
|
20.7%
6/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/50 • Up to 106 weeks
|
6.9%
2/29 • Up to 106 weeks
|
10.0%
2/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
6.0%
3/50 • Up to 106 weeks
|
6.9%
2/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
6.0%
3/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Stomatitis
|
4.0%
2/50 • Up to 106 weeks
|
6.9%
2/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
2.0%
1/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.0%
1/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Colitis
|
2.0%
1/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Cheilitis
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Dry mouth
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Gingival bleeding
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Lip oedema
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Odynophagia
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Poor dental condition
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Regurgitation
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Gastrointestinal disorders
Toothache
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
24.0%
12/50 • Up to 106 weeks
|
24.1%
7/29 • Up to 106 weeks
|
15.0%
3/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.0%
6/50 • Up to 106 weeks
|
20.7%
6/29 • Up to 106 weeks
|
20.0%
4/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
8.0%
4/50 • Up to 106 weeks
|
10.3%
3/29 • Up to 106 weeks
|
10.0%
2/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
4.0%
2/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.0%
2/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
4.0%
2/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
4.0%
2/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
4.0%
2/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
4.0%
2/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.0%
1/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hiccups
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Infections and infestations
Pneumonia
|
2.0%
1/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Lower respiratory tract infection
|
4.0%
2/50 • Up to 106 weeks
|
17.2%
5/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Respiratory tract infection
|
4.0%
2/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
10.0%
2/20 • Up to 106 weeks
|
|
Infections and infestations
Urinary tract infection
|
2.0%
1/50 • Up to 106 weeks
|
10.3%
3/29 • Up to 106 weeks
|
15.0%
3/20 • Up to 106 weeks
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
2/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
10.0%
2/20 • Up to 106 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
2/50 • Up to 106 weeks
|
6.9%
2/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Oral candidiasis
|
4.0%
2/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Infections and infestations
Candida infection
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Cellulitis
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Fungal infection
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Infections and infestations
Gastroenteritis
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Impetigo
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Oesophageal candidiasis
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Oral herpes zoster
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Otitis media
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Pharyngitis
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Rhinitis
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Sinusitis
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Skin candida
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Tonsillitis
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Infections and infestations
Toxic shock syndrome
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
32.0%
16/50 • Up to 106 weeks
|
31.0%
9/29 • Up to 106 weeks
|
25.0%
5/20 • Up to 106 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
8.0%
4/50 • Up to 106 weeks
|
10.3%
3/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
8.0%
4/50 • Up to 106 weeks
|
6.9%
2/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
4.0%
2/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
10.0%
2/20 • Up to 106 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.0%
2/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
12.0%
6/50 • Up to 106 weeks
|
10.3%
3/29 • Up to 106 weeks
|
20.0%
4/20 • Up to 106 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
12.0%
6/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
10.0%
2/20 • Up to 106 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
8.0%
4/50 • Up to 106 weeks
|
6.9%
2/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.0%
1/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
15.0%
3/20 • Up to 106 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
6.0%
3/50 • Up to 106 weeks
|
6.9%
2/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
2.0%
1/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
2.0%
1/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.0%
1/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.0%
1/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Musculoskeletal and connective tissue disorders
Greater trochanteric pain syndrome
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
14.0%
7/50 • Up to 106 weeks
|
13.8%
4/29 • Up to 106 weeks
|
15.0%
3/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.0%
3/50 • Up to 106 weeks
|
10.3%
3/29 • Up to 106 weeks
|
10.0%
2/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
6.0%
3/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.0%
2/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
4.0%
2/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
10.0%
2/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Lichen sclerosus
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Skin and subcutaneous tissue disorders
Skin mass
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Blood and lymphatic system disorders
Anaemia
|
20.0%
10/50 • Up to 106 weeks
|
17.2%
5/29 • Up to 106 weeks
|
10.0%
2/20 • Up to 106 weeks
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
4.0%
2/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/50 • Up to 106 weeks
|
6.9%
2/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Blood and lymphatic system disorders
Coagulopathy
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Blood and lymphatic system disorders
Microcytic anaemia
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Nervous system disorders
Headache
|
6.0%
3/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Nervous system disorders
Dizziness
|
4.0%
2/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Nervous system disorders
Paraesthesia
|
4.0%
2/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Nervous system disorders
Amnesia
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Nervous system disorders
Hypersomnia
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Nervous system disorders
Memory impairment
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Nervous system disorders
Monoparesis
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Nervous system disorders
Neurotoxicity
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Nervous system disorders
Somnolence
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Nervous system disorders
Vocal cord paralysis
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
6.0%
3/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Hepatobiliary disorders
Immune-mediated hepatitis
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Renal and urinary disorders
Renal failure
|
4.0%
2/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Renal and urinary disorders
Polyuria
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Renal and urinary disorders
Proteinuria
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Renal and urinary disorders
Renal impairment
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Renal and urinary disorders
Urinary retention
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Renal and urinary disorders
Urinary tract disorder
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Psychiatric disorders
Insomnia
|
10.0%
5/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Psychiatric disorders
Anxiety
|
4.0%
2/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Psychiatric disorders
Depression
|
4.0%
2/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Psychiatric disorders
Adjustment disorder
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Psychiatric disorders
Confusional state
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Psychiatric disorders
Delirium
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Psychiatric disorders
Depressed mood
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Psychiatric disorders
Persistent depressive disorder
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Injury, poisoning and procedural complications
Fall
|
2.0%
1/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
4.0%
2/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Injury, poisoning and procedural complications
Radiation skin injury
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Cardiac disorders
Pericardial effusion
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Cardiac disorders
Sinus tachycardia
|
4.0%
2/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Cardiac disorders
Bundle branch block right
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Cardiac disorders
Sinus node dysfunction
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Vascular disorders
Hypertension
|
4.0%
2/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Vascular disorders
Deep vein thrombosis
|
4.0%
2/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Vascular disorders
Hypotension
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Vascular disorders
Orthostatic hypotension
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Vascular disorders
Peripheral artery occlusion
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Vascular disorders
Varicose vein
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Ear and labyrinth disorders
Tinnitus
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
|
Ear and labyrinth disorders
Ear haemorrhage
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Endocrine disorders
Diabetes insipidus
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Endocrine disorders
Hyperthyroidism
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Eye disorders
Conjunctivitis allergic
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Eye disorders
Dry eye
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Eye disorders
Photopsia
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Eye disorders
Vision blurred
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/50 • Up to 106 weeks
|
3.4%
1/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
2.0%
1/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
0.00%
0/20 • Up to 106 weeks
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/50 • Up to 106 weeks
|
0.00%
0/29 • Up to 106 weeks
|
5.0%
1/20 • Up to 106 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place