Trial Outcomes & Findings for CMX001 in Post-transplant Patients With BK Virus Viruria (NCT NCT00793598)
NCT ID: NCT00793598
Last Updated: 2021-08-16
Results Overview
The primary objective of this study was to determine the safety and tolerability of brincidofovir (BCV) in post-transplant patients with BK virus viruria. Safety measures included adverse events, clinical laboratory values, vital signs, and renal and gastrointestinal function.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
29 participants
Primary outcome timeframe
35 days (Day 0 to Day 35)
Results posted on
2021-08-16
Participant Flow
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in further analyses.
Participant milestones
| Measure |
10 mg BCV BIW RT
Renal transplant (RT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
|
10 mg BCV BIW HCT
Hematopoietic stem cell transplant (HCT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
|
20 mg BCV QW HCT
Hematopoietic stem cell transplant (HCT) recipients who received 20 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, and 14.
|
Placebo BIW HCT
Hematopoietic stem cell transplant (HCT) recipients who received placebo twice weekly (BIW) under Amendment 2.
|
40 mg BCV QW RT
Renal transplant (RT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
|
40 mg BCV QW HCT
Hematopoietic stem cell transplant (HCT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
|
Placebo QW RT
Renal transplant (RT) recipients who received placebo once weekly (QW) under Amendment 3.
|
Placebo QW HCT
Hematopoietic stem cell transplant (HCT) recipients who received placebo once weekly (QW) under Amendment 3.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
1
|
1
|
2
|
8
|
8
|
4
|
4
|
|
Overall Study
COMPLETED
|
1
|
0
|
1
|
2
|
8
|
7
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
10 mg BCV BIW RT
Renal transplant (RT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
|
10 mg BCV BIW HCT
Hematopoietic stem cell transplant (HCT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
|
20 mg BCV QW HCT
Hematopoietic stem cell transplant (HCT) recipients who received 20 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, and 14.
|
Placebo BIW HCT
Hematopoietic stem cell transplant (HCT) recipients who received placebo twice weekly (BIW) under Amendment 2.
|
40 mg BCV QW RT
Renal transplant (RT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
|
40 mg BCV QW HCT
Hematopoietic stem cell transplant (HCT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
|
Placebo QW RT
Renal transplant (RT) recipients who received placebo once weekly (QW) under Amendment 3.
|
Placebo QW HCT
Hematopoietic stem cell transplant (HCT) recipients who received placebo once weekly (QW) under Amendment 3.
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Patient Request
|
0
|
1
|
0
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Subject not dosed
|
0
|
0
|
0
|
0
|
0
|
1
|
0
|
0
|
Baseline Characteristics
CMX001 in Post-transplant Patients With BK Virus Viruria
Baseline characteristics by cohort
| Measure |
10 mg BCV BIW
n=2 Participants
Subjects who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
|
20 mg BCV QW
n=1 Participants
Subjects who received 20 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, and 14.
|
Placebo BIW
n=2 Participants
Subjects who received placebo twice weekly (BIW) under Amendment 2.
|
40 mg BCV QW
n=15 Participants
Subjects who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0 7, 14, 21, and 28.
|
Placebo QW
n=8 Participants
Subjects who received placebo once weekly (QW) under Amendment 3.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
40 years
STANDARD_DEVIATION 10 • n=5 Participants
|
60 years
STANDARD_DEVIATION 0 • n=7 Participants
|
60 years
STANDARD_DEVIATION 2 • n=5 Participants
|
55.5 years
STANDARD_DEVIATION 15.14 • n=4 Participants
|
51.0 years
STANDARD_DEVIATION 10.46 • n=21 Participants
|
51.5 years
STANDARD_DEVIATION 14.2 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
|
Type of transplant received
Hematopoietic stem cell transplant recipients
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
|
Type of transplant received
Renal transplant recipients
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 35 days (Day 0 to Day 35)Population: 1 subject in the 40 mg BCV QW HCT treatment arm was not dosed with BCV and, therefore, was not included in this analysis.
The primary objective of this study was to determine the safety and tolerability of brincidofovir (BCV) in post-transplant patients with BK virus viruria. Safety measures included adverse events, clinical laboratory values, vital signs, and renal and gastrointestinal function.
Outcome measures
| Measure |
10 mg BCV BIW RT
n=1 Participants
Renal transplant (RT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly
|
10 mg BCV BIW HCT
n=1 Participants
Hematopoietic stem cell transplant (HCT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
|
20 mg BCV BIW HCT
n=1 Participants
Hematopoietic stem cell transplant (HCT) recipients who received 20 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, and 14.
|
Placebo BIW HCT
n=2 Participants
Hematopoietic stem cell transplant (HCT) recipients who received placebo twice weekly (BIW) under Amendment 2.
|
40 mg BCV QW RT
n=8 Participants
Renal transplant (RT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
|
40 mg BCV QW HCT
n=7 Participants
Hematopoietic stem cell transplant (HCT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
|
Placebo QW RT
n=4 Participants
Renal transplant (RT) recipients who received placebo once weekly (QW) under Amendment 3.
|
Placebo QW HCT
n=4 Participants
Hematopoietic stem cell transplant (HCT) recipients who received placebo once weekly (QW) under Amendment 3.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Adverse Events in Post-Transplant Patients With BK Virus Viruria
Subjects who experienced at least 1 an adverse event
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
8 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
|
Number of Adverse Events in Post-Transplant Patients With BK Virus Viruria
Subjects who did not experience an adverse event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Hematopoietic stem cell (HCT) recipients and renal transplant (RT) recipients enrolled under Amendment 3 who had detectable BK viruria at baseline (Day 0). 1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
The percentage of subjects who cleared the virus was calculated. Concentrations below the lower limit of quantification were indicated as below the limit of quantitation and were considered "cleared".
Outcome measures
| Measure |
10 mg BCV BIW RT
n=15 Participants
Renal transplant (RT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly
|
10 mg BCV BIW HCT
n=8 Participants
Hematopoietic stem cell transplant (HCT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
|
20 mg BCV BIW HCT
Hematopoietic stem cell transplant (HCT) recipients who received 20 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, and 14.
|
Placebo BIW HCT
Hematopoietic stem cell transplant (HCT) recipients who received placebo twice weekly (BIW) under Amendment 2.
|
40 mg BCV QW RT
Renal transplant (RT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
|
40 mg BCV QW HCT
Hematopoietic stem cell transplant (HCT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
|
Placebo QW RT
Renal transplant (RT) recipients who received placebo once weekly (QW) under Amendment 3.
|
Placebo QW HCT
Hematopoietic stem cell transplant (HCT) recipients who received placebo once weekly (QW) under Amendment 3.
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Patients Who Achieved BK Viruria Resolution
HCT recipients · Subjects who did not clear viruria
|
6 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Who Achieved BK Viruria Resolution
RT Recipients · Subjects who cleared viruria
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Who Achieved BK Viruria Resolution
RT Recipients · Subjects who did not clear viruria
|
7 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Percentage of Patients Who Achieved BK Viruria Resolution
HCT recipients · Subjects who cleared viruria
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: 28 daysPopulation: Hematopoietic stem cell (HCT) recipients and renal transplant (RT) recipients enrolled under Amendment 3 who had detectable BK viruria at baseline (Day 0). 1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
A 2-log drop in viruria or viremia or clearance of virus was considered significant. Percentages of subjects with a 2-log drop in viral load were calculated.
Outcome measures
| Measure |
10 mg BCV BIW RT
n=15 Participants
Renal transplant (RT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly
|
10 mg BCV BIW HCT
n=8 Participants
Hematopoietic stem cell transplant (HCT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
|
20 mg BCV BIW HCT
Hematopoietic stem cell transplant (HCT) recipients who received 20 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, and 14.
|
Placebo BIW HCT
Hematopoietic stem cell transplant (HCT) recipients who received placebo twice weekly (BIW) under Amendment 2.
|
40 mg BCV QW RT
Renal transplant (RT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
|
40 mg BCV QW HCT
Hematopoietic stem cell transplant (HCT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
|
Placebo QW RT
Renal transplant (RT) recipients who received placebo once weekly (QW) under Amendment 3.
|
Placebo QW HCT
Hematopoietic stem cell transplant (HCT) recipients who received placebo once weekly (QW) under Amendment 3.
|
|---|---|---|---|---|---|---|---|---|
|
Number of Patients Who Achieved a Clinically Significant Decrease in BK Viruria
HCT recipients · Subjects without 2-log drop from Day 0
|
6 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients Who Achieved a Clinically Significant Decrease in BK Viruria
RT Recipients · Subjects with 2-log drop from Day 0
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients Who Achieved a Clinically Significant Decrease in BK Viruria
HCT recipients · Subjects with 2-log drop from Day 0
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Number of Patients Who Achieved a Clinically Significant Decrease in BK Viruria
RT Recipients · Subjects without 2-log drop from Day 0
|
8 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
—
|
—
|
Adverse Events
10 mg BCV BIW RT
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
10 mg BCV BIW HCT
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
20 mg BCV QW HCT
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Placebo BIW HCT
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
40 mg BCV QW RT
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
40 mg BCV QW HCT
Serious events: 2 serious events
Other events: 7 other events
Deaths: 0 deaths
Placebo QW RT
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Placebo QW HCT
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
10 mg BCV BIW RT
n=1 participants at risk
Renal transplant (RT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
|
10 mg BCV BIW HCT
n=1 participants at risk
Hematopoietic stem cell transplant (HCT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
|
20 mg BCV QW HCT
n=1 participants at risk
Hematopoietic stem cell transplant (HCT) recipients who received 20 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, and 14.
|
Placebo BIW HCT
n=2 participants at risk
Hematopoietic stem cell transplant (HCT) recipients who received placebo twice weekly (BIW) under Amendment 2.
|
40 mg BCV QW RT
n=8 participants at risk
Renal transplant (RT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
|
40 mg BCV QW HCT
n=7 participants at risk
Hematopoietic stem cell transplant (HCT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
|
Placebo QW RT
n=4 participants at risk
Renal transplant (RT) recipients who received placebo once weekly (QW) under Amendment 3.
|
Placebo QW HCT
n=4 participants at risk
Hematopoietic stem cell transplant (HCT) recipients who received placebo once weekly (QW) under Amendment 3.
|
|---|---|---|---|---|---|---|---|---|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Immune system disorders
Acute graft versus host disease skin
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Immune system disorders
Acute graft versus host disease in intestine
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Blood and lymphatic system disorders
Methemoglobinemia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Immune system disorders
Pancreas transplant rejection
|
100.0%
1/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
Other adverse events
| Measure |
10 mg BCV BIW RT
n=1 participants at risk
Renal transplant (RT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
|
10 mg BCV BIW HCT
n=1 participants at risk
Hematopoietic stem cell transplant (HCT) recipients who received 10 mg brincidofovir (BCV) administered twice weekly (BIW) on Days 0, 3, 7, 10, and 14.
|
20 mg BCV QW HCT
n=1 participants at risk
Hematopoietic stem cell transplant (HCT) recipients who received 20 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, and 14.
|
Placebo BIW HCT
n=2 participants at risk
Hematopoietic stem cell transplant (HCT) recipients who received placebo twice weekly (BIW) under Amendment 2.
|
40 mg BCV QW RT
n=8 participants at risk
Renal transplant (RT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
|
40 mg BCV QW HCT
n=7 participants at risk
Hematopoietic stem cell transplant (HCT) recipients who received 40 mg brincidofovir (BCV) administered once weekly (QW) on Days 0, 7, 14, 21, and 28.
|
Placebo QW RT
n=4 participants at risk
Renal transplant (RT) recipients who received placebo once weekly (QW) under Amendment 3.
|
Placebo QW HCT
n=4 participants at risk
Hematopoietic stem cell transplant (HCT) recipients who received placebo once weekly (QW) under Amendment 3.
|
|---|---|---|---|---|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscle tightness
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
28.6%
2/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
100.0%
1/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
37.5%
3/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
28.6%
2/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
2/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
28.6%
2/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
1/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
42.9%
3/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
2/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
2/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
General disorders
Chest discomfort
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
General disorders
Early satiety
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
General disorders
Fatigue
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
1/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
28.6%
2/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
General disorders
Oedema peripheral
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
57.1%
4/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
General disorders
Thirst
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
28.6%
2/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
1/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
2/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
28.6%
2/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
2/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
42.9%
3/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
1/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
28.6%
2/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Gastrointestinal disorders
Abdominal distention
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
1/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Eye disorders
Eye haemorrhage
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Eye disorders
Vision blurred
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
1/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Injury, poisoning and procedural complications
Post procedural haemorrhage
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Investigations
Blood amylase increased
|
100.0%
1/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Investigations
Lipase increased
|
100.0%
1/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Renal and urinary disorders
Urinary retention
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Metabolism and nutrition disorders
Anorexia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Immune system disorders
Graft versus host disease
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Infections and infestations
Cystitis
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Infections and infestations
Oral fungal infection
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Investigations
Haematocrit decreased
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
2/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
2/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
2/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
100.0%
2/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
2/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
1/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oxygen saturation decreased
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
1/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Investigations
Blood lactate dehydrogenase increased
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
1/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
1/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Endocrine disorders
Androgen deficiency
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
1/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Nervous system disorders
Tremor
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
1/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
100.0%
1/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
100.0%
1/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Metabolism and nutrition disorders
Hyperlipidemia
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
50.0%
1/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Vascular disorders
Hypertension
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
12.5%
1/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Gastrointestinal disorders
Reflux oesophagitis
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
14.3%
1/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/1 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/2 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/8 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/7 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
0.00%
0/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
25.0%
1/4 • Day 0 to Day 35
1 HCT subject in the 40 mg BCV QW treatment arm was not dosed with BCV and, therefore, is not included in this analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Within 12 months after the end of the Study at all sites, if no publication of the overall multi-center results has been made, institutions are entitled to publish their locally obtained results, provided the Sponsor is given opportunity to review and comment.
- Publication restrictions are in place
Restriction type: OTHER