Trial Outcomes & Findings for Phase 2 Study to Evaluate Brincidofovir for the Prevention of Adenovirus Disease (NCT NCT01241344)
NCT ID: NCT01241344
Last Updated: 2021-07-21
Results Overview
The primary objective of this study was to evaluate the safety and efficacy of preemptive treatment with brincidofovir (BCV) versus placebo for the prevention of adenovirus (AdV) disease in recipients of hematopoietic stem cell transplantation (HCT) with asymptomatic AdV viremia. The outcome measure for the primary endpoint was treatment failure, a composite endpoint that consisted of the following: * Progression to probable AdV disease (other positive causes/agents have been ruled out and subject has disease-targeted organ-specific signs or symptoms) or definitive AdV disease (AdV detected in disease-targeted organ/system biopsy via antigen/immunohistochemistry, culture, and/or polymerase chain reaction and has at least 1 disease-targeted organ-specific sign or symptom); or * Increasing AdV viremia (defined as an increase from baseline in AdV viremia by ≥1 log10, confirmed on a second measurement, at least 1 week apart) and requiring discontinuation from blinded therapy.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
52 participants
Primary outcome timeframe
12 weeks
Results posted on
2021-07-21
Participant Flow
Randomized (blinded) subjects who considered treatment failures were offered open-label BCV therapy. These subjects followed the same schedule of assessments, beginning at Day 0 for up to 12 weeks followed by 4 weeks of post-treatment follow-up. Additionally, 4 subjects who had not been previously enrolled in the randomized (blinded) phase of the study were enrolled directly to the open-label arm.
Participant milestones
| Measure |
Brincidofovir BIW
Randomized (Blinded) Phase
* Adult subjects: 200 mg brincidofovir (BCV) administered as four 50 mg tablets taken orally twice weekly (BIW).
* Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200 mg) administered using a 10 mg/mL liquid formulation taken orally BIW (as 2 mg/kg).
|
Brincidofovir QW
Randomized (Blinded) Phase
* Adult subjects: 200 mg brincidofovir (BCV) administered as two 50 mg tablets taken orally once weekly (QW).
* Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200 mg) administered using a 10 mg/mL liquid formulation taken orally QW (as 4 mg/kg)
|
Placebo
Randomized (Blinded) Phase
* Adult subjects: Matching placebo tablets taken orally once weekly (QW; 2 tablets) or twice weekly (BIW; 4 tablets).
* Pediatric subjects: Matching liquid placebo taken orally QW or BIW.
|
Directly to Open-label
Subjects who were enrolled directly to open-label and had not been previously randomized (n=4) received 200 mg brincidofovir (BCV) administered as four 50 mg tablets taken orally twice weekly (BIW).
This number does not include subjects who were previously randomized and moved to open-label (n=8), as they are represented in their previously randomized arm.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
14
|
16
|
18
|
4
|
|
Overall Study
Randomized to Open-label
|
3
|
4
|
5
|
0
|
|
Overall Study
COMPLETED
|
9
|
7
|
9
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
9
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Phase 2 Study to Evaluate Brincidofovir for the Prevention of Adenovirus Disease
Baseline characteristics by cohort
| Measure |
BCV BIW
n=14 Participants
Randomized (Blinded) Phase
* Adult subjects: 200 mg brincidofovir (BCV) administered as four 50 mg tablets taken orally twice weekly (BIW).
* Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200 mg) administered using a 10 mg/mL liquid formulation taken orally BIW (as 2 mg/kg).
|
BCV QW
n=16 Participants
Randomized (Blinded) Phase
* Adult subjects: 200 mg brincidofovir (BCV) administered as four 50 mg tablets taken orally once weekly (QW).
* Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200 mg) administered using a 10 mg/mL liquid formulation taken orally QW (as 4 mg/kg).
|
Placebo
n=18 Participants
Randomized (Blinded) Phase
* Adult subjects: Matching placebo tablets taken orally once weekly (QW) or twice weekly (BIW).
* Pediatric subjects: Matching liquid placebo taken orally QW or BIW.
|
BCV Direct to Open-Label
n=4 Participants
Subjects who were enrolled directly to open-label and had not been previously randomized (n=4) received 200 mg brincidofovir (BCV) administered as four 50 mg tablets taken orally twice weekly (BIW).
This number does not include subjects who were previously randomized and moved to open-label (n=8), as they are represented in their previously randomized arm.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
12.6 years
STANDARD_DEVIATION 14.64 • n=5 Participants
|
15.7 years
STANDARD_DEVIATION 20.67 • n=7 Participants
|
13.8 years
STANDARD_DEVIATION 12.35 • n=5 Participants
|
23.8 years
STANDARD_DEVIATION 21.55 • n=4 Participants
|
14.8 years
STANDARD_DEVIATION 16.44 • n=21 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
37 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: 12 weeksPopulation: Intent-to-Treat Population, defined as all randomized subjects who took at least 1 dose of study drug. Note that the subjects who were enrolled directly to open-label and not randomized are not included in this data.
The primary objective of this study was to evaluate the safety and efficacy of preemptive treatment with brincidofovir (BCV) versus placebo for the prevention of adenovirus (AdV) disease in recipients of hematopoietic stem cell transplantation (HCT) with asymptomatic AdV viremia. The outcome measure for the primary endpoint was treatment failure, a composite endpoint that consisted of the following: * Progression to probable AdV disease (other positive causes/agents have been ruled out and subject has disease-targeted organ-specific signs or symptoms) or definitive AdV disease (AdV detected in disease-targeted organ/system biopsy via antigen/immunohistochemistry, culture, and/or polymerase chain reaction and has at least 1 disease-targeted organ-specific sign or symptom); or * Increasing AdV viremia (defined as an increase from baseline in AdV viremia by ≥1 log10, confirmed on a second measurement, at least 1 week apart) and requiring discontinuation from blinded therapy.
Outcome measures
| Measure |
BCV BIW
n=14 Participants
Randomized (Blinded) Phase
* Adult subjects: 200 mg brincidofovir (BCV) administered as four 50 mg tablets taken orally twice weekly (BIW).
* Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200 mg) administered using a 10 mg/mL liquid formulation taken orally BIW (as 2 mg/kg).
|
BCV QW
n=16 Participants
Randomized (Blinded) Phase
* Adult subjects: 200 mg brincidofovir (BCV) administered as two 50mg tablets taken orally once weekly (QW).
* Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200 mg) administered using a 10 mg/mL liquid formulation taken orally QW (as 4 mg/kg).
|
Placebo
n=18 Participants
Randomized (Blinded) Phase
* Adult subjects: Matching placebo tablets taken orally either once weekly (QW) or twice weekly (BIW).
* Pediatric subjects: Matching liquid placebo taken orally either QW or BIW.
|
|---|---|---|---|
|
Number of Participants With Clinically Significant AdV Infection
|
3 Participants
|
6 Participants
|
6 Participants
|
Adverse Events
BCV BIW
Serious events: 6 serious events
Other events: 13 other events
Deaths: 0 deaths
BCV QW
Serious events: 7 serious events
Other events: 14 other events
Deaths: 0 deaths
Placebo
Serious events: 6 serious events
Other events: 16 other events
Deaths: 0 deaths
BCV Open-Label
Serious events: 8 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
BCV BIW
n=14 participants at risk
Randomized (Blinded) Phase
* Adult subjects: 200 mg brincidofocir (BCV) administered as four 50mg tablets orally twice weekly (BIW).
* Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200mg) administered using a 10 mg/mL liquid formulation taken orally BIW (as 2 mg/kg).
|
BCV QW
n=16 participants at risk
Randomized (Blinded) Phase
* Adult subjects: 200 mg brincidofovir (BCV) administered as two 50mg tablets orally once weekly (QW).
* Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200mg) administered using a 10 mg/mL liquid formulation taken orally QW (as 4 mg/kg).
|
Placebo
n=18 participants at risk
Randomized (Blinded) Phase
* Adult subjects: Matching placebo tablets taken orally either once weekly (QW) or twice weekly (BIW).
* Pediatric subjects: Matching liquid placebo taken orally QW or BIW.
|
BCV Open-Label
n=12 participants at risk
Subjects who were enrolled directly to open-label and not randomized (n=4) and subjects who were previously randomized and moved to open-label (n=8) received 200 mg brincidofovir (BCV) administered as four 50 mg tablets taken orally twice weekly (BIW).
|
|---|---|---|---|---|
|
Infections and infestations
BK virus infection
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Influenza
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
2/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Diarrhoea
|
14.3%
2/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
2/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Immune system disorders
Acute graft versus host disease
|
14.3%
2/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
12.5%
2/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Vascular disorders
Hypotension
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Congenital, familial and genetic disorders
Metachromatic leukodystrophy
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Blood urea increased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
General disorders
Multi-organ failure
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Septic shock
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Vascular disorders
Hypertension
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
Other adverse events
| Measure |
BCV BIW
n=14 participants at risk
Randomized (Blinded) Phase
* Adult subjects: 200 mg brincidofocir (BCV) administered as four 50mg tablets orally twice weekly (BIW).
* Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200mg) administered using a 10 mg/mL liquid formulation taken orally BIW (as 2 mg/kg).
|
BCV QW
n=16 participants at risk
Randomized (Blinded) Phase
* Adult subjects: 200 mg brincidofovir (BCV) administered as two 50mg tablets orally once weekly (QW).
* Pediatric subjects: 4 mg/kg BCV (not to exceed a total single dose of 200mg) administered using a 10 mg/mL liquid formulation taken orally QW (as 4 mg/kg).
|
Placebo
n=18 participants at risk
Randomized (Blinded) Phase
* Adult subjects: Matching placebo tablets taken orally either once weekly (QW) or twice weekly (BIW).
* Pediatric subjects: Matching liquid placebo taken orally QW or BIW.
|
BCV Open-Label
n=12 participants at risk
Subjects who were enrolled directly to open-label and not randomized (n=4) and subjects who were previously randomized and moved to open-label (n=8) received 200 mg brincidofovir (BCV) administered as four 50 mg tablets taken orally twice weekly (BIW).
|
|---|---|---|---|---|
|
Investigations
Haemoglobin decreased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
BK virus infection
|
21.4%
3/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
18.8%
3/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
11.1%
2/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
2/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Candidiasis
|
14.3%
2/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
11.1%
2/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Cytomegalovirus viraemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
3/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Enterococcal bacteraemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
25.0%
3/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Klebsiella infection
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
11.1%
2/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Sinusitis
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Cellulitis
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Cytomegalovirus infection
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Enterococcal infection
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Epstein-Barr viraemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Human herpesvirus 6 infection
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Sepsis
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Upper respiratory tract infection
|
14.3%
2/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Adenoviral upper respiratory infection
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Atypical mycobacterial pneumonia
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Candida pneumonia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Encephalitic infection
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Escherichia bacteraemia
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Eye infection
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Gastrointestinal candidiasis
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Herpes simplex
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Hordeolum
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Lobar pneumonia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Oral herpes
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Paronychia
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Pneumonia Klebsiella
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Rhinovirus infection
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Urinary tract infection
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Urinary tract infection fungal
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Viral rhinitis
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Diarrhoea
|
57.1%
8/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
37.5%
6/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
27.8%
5/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
50.0%
6/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Nausea
|
14.3%
2/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
12.5%
2/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
22.2%
4/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
41.7%
5/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Vomiting
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
25.0%
4/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
22.2%
4/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
25.0%
3/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.3%
2/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
11.1%
2/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
25.0%
3/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
2/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
2/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Ascites
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Caecitis
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Colitis
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Gingival ulceration
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Melaena
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Salivary hypersecretion
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
18.8%
3/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
2/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
25.0%
3/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
12.5%
2/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Tachypnoea
|
14.3%
2/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Lymphocyte count decreased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Hyperventilation
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary hypertension
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Stridor
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
General disorders
Pyrexia
|
21.4%
3/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
18.8%
3/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
22.2%
4/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
25.0%
3/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
General disorders
Fatigue
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
18.8%
3/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
General disorders
Chills
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
General disorders
Implant site pain
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
General disorders
Discomfort
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
General disorders
Medical device complication
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
General disorders
Oedema
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
General disorders
Pain
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
3/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
25.0%
3/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
18.8%
3/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
2/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
25.0%
3/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
2/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
11.1%
2/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Fluid overload
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Hypermagnesaemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Fluid imbalance
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Food intolerance
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Hyperphosphataemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Alanine aminotransferase increased
|
14.3%
2/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
22.2%
4/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Aspartate aminotransferase increased
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
22.2%
4/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Blood creatinine increased
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Blood urea increased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
2/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
12.5%
2/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
2/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Weight increased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
2/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Blood amylase increased
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Weight decreased
|
14.3%
2/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
White blood cell count decreased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
White blood cell count increased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Blood sodium increased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Body temperature fluctuation
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
C-reactive protein increased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Cardiac output decreased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
CD4 lymphocytes decreased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Fungal test positive
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Monocyte count decreased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Polyomavirus test positive
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Serum ferritin increased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Transaminases increased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Investigations
Urine output decreased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Immune system disorders
Acute graft versus host disease
|
50.0%
7/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
25.0%
4/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
3/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
41.7%
5/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Immune system disorders
Hypogammaglobulinaemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Nervous system disorders
Headache
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
12.5%
2/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Nervous system disorders
Dizziness
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Nervous system disorders
Tremor
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Nervous system disorders
Extrapyramidal disorder
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Nervous system disorders
Intracranial pressure increased
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Nervous system disorders
Neurological symptom
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Nervous system disorders
Nystagmus
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Nervous system disorders
Sedation
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Nervous system disorders
Somnolence
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Renal and urinary disorders
Renal failure
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
11.1%
2/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Renal and urinary disorders
Renal failure acute
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Renal and urinary disorders
Azotaemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Renal and urinary disorders
Bladder obstruction
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Renal and urinary disorders
Urinary incontinence
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Blood and lymphatic system disorders
Neutropenia
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
11.1%
2/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
2/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Blood and lymphatic system disorders
Anaemia
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
14.3%
2/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Blood and lymphatic system disorders
Thrombotic microangiopathy
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Blood and lymphatic system disorders
Methaemoglobinaemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Vascular disorders
Hypotension
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
3/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
2/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Vascular disorders
Hypertension
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
2/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Vascular disorders
Haematoma
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
12.5%
2/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Injury, poisoning and procedural complications
Refractoriness to platelet transfusion
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
11.1%
2/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Psychiatric disorders
Depression
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Psychiatric disorders
Hallucination
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Skin and subcutaneous tissue disorders
Dermatitis diaper
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Skin and subcutaneous tissue disorders
Hypertrichosis
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Skin and subcutaneous tissue disorders
Skin disorder
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Cardiac disorders
Pericardial effusion
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
11.1%
2/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Surgical and medical procedures
Gastrointestinal tube insertion
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
11.1%
2/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Ear and labyrinth disorders
Ear pain
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Enterococcal sepsis
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Gingival abscess
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Influenza
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Pneumonia fungal
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Infections and infestations
Septic shock
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
16.7%
2/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Respiratory, thoracic and mediastinal disorders
Obliterative bronchiolitis
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
General disorders
Multi-organ failure
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
General disorders
Drug withdrawal syndrome
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Nervous system disorders
Convulsion
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Vascular disorders
Shock haemorrhagic
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Skin and subcutaneous tissue disorders
Toxic epidermal necrolysis
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Cardiac disorders
Cardiac failure
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
8.3%
1/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Musculoskeletal and connective tissue disorders
Muscle atrophy
|
7.1%
1/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia recurrent
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
5.6%
1/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
|
Congenital, familial and genetic disorders
Metachromatic leukodystrophy
|
0.00%
0/14
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
6.2%
1/16
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/18
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
0.00%
0/12
Note that 8 subjects in the BCV open-label arm were previously randomized to 1 of the 3 blinded treatment arms: BCV BIW, BCV QW, or placebo. The adverse events reported for these subjects are presented according to what treatment arm they were under at the time the adverse event occurred.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Within 18 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. Institution publication may be delayed up to an additional 3 months to allow Sponsor to seek patent protection.
- Publication restrictions are in place
Restriction type: OTHER