Trial Outcomes & Findings for Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin) (NCT NCT01017575)
NCT ID: NCT01017575
Last Updated: 2015-09-11
Results Overview
eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA \<15 IU/mL, the lower limit of detection at both Weeks 4 and 12.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
55 participants
Primary outcome timeframe
From Week 4 up to Week 12
Results posted on
2015-09-11
Participant Flow
The study was conducted at 6 sites in Japan.
A total of 55 participants were enrolled, of which 43 participants were randomized and 42 were treated. 12 participants were not randomized because 10 no longer met study criteria and 2 withdrew consent; 1 randomized participant was not treated due enlarged lymph node.
Participant milestones
| Measure |
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
8
|
9
|
8
|
8
|
9
|
|
Overall Study
COMPLETED
|
7
|
7
|
8
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
0
|
1
|
3
|
Reasons for withdrawal
| Measure |
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
|---|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
1
|
1
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)
Baseline characteristics by cohort
| Measure |
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 Participants
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=9 Participants
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 Participants
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=8 Participants
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=9 Participants
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Customized
<65 years
|
7 participants
n=5 Participants
|
8 participants
n=7 Participants
|
6 participants
n=5 Participants
|
6 participants
n=4 Participants
|
8 participants
n=21 Participants
|
35 participants
n=8 Participants
|
|
Age, Customized
>=65 years
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
1 participants
n=21 Participants
|
7 participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
22 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: From Week 4 up to Week 12Population: All treated participants who received at least 1 dose of study therapy.
eRVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA \<15 IU/mL, the lower limit of detection at both Weeks 4 and 12.
Outcome measures
| Measure |
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 Participants
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=9 Participants
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 Participants
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=8 Participants
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=9 Participants
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Extended Rapid Virologic Response (eRVR)
|
12.5 percentage of participants
|
66.7 percentage of participants
|
62.5 percentage of participants
|
62.5 percentage of participants
|
77.8 percentage of participants
|
SECONDARY outcome
Timeframe: Week 4Population: All treated participants who received at least 1 dose of study therapy.
RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA \<15 IU/mL, the lower limit of detection at Week 4.
Outcome measures
| Measure |
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 Participants
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=9 Participants
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 Participants
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=8 Participants
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=9 Participants
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Rapid Virologic Response (RVR)
|
12.5 percentage of participants
|
77.8 percentage of participants
|
62.5 percentage of participants
|
62.5 percentage of participants
|
88.9 percentage of participants
|
SECONDARY outcome
Timeframe: Week 12Population: All treated participants who received at least 1 dose of study therapy.
cEVR was defined as hepatitis C virus RNA \<15 IU/mL at Week 12.
Outcome measures
| Measure |
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 Participants
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=9 Participants
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 Participants
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=8 Participants
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=9 Participants
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a Complete Early Virologic Response (cEVR)
|
62.5 percentage of participants
|
88.9 percentage of participants
|
100 percentage of participants
|
87.5 percentage of participants
|
88.9 percentage of participants
|
SECONDARY outcome
Timeframe: Follow up Week 12, Follow up Week 24Population: All treated participants who received at least 1 dose of study therapy.
SVR at Follow-up Week 12 (SVR12) and SVR at Follow-up week 24 (SVR24) was defined as hepatitis C virus (HCV) RNA \<15 IU/mL at follow-up Weeks 12 and 24.
Outcome measures
| Measure |
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 Participants
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=9 Participants
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 Participants
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=8 Participants
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=9 Participants
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
|---|---|---|---|---|---|
|
Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24
SVR12
|
75 percentage of participants
|
88.9 percentage of participants
|
100 percentage of participants
|
50 percentage of participants
|
77.8 percentage of participants
|
|
Percentage of Participants With a Sustained Virologic Response (SVR) at Follow-up Week 12 and Follow-up Week 24
SVR24
|
75 percentage of participants
|
88.9 percentage of participants
|
100 percentage of participants
|
50 percentage of participants
|
77.8 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline up to 30 days after last dose of study drugPopulation: All treated participants who received at least 1 dose of study therapy.
AE was defined as any new unfavorable symptom, sign, or disease or worsening of a preexisting condition that does not has a causal relationship with treatment. SAE was defined as a medical event that at any dose resulted in death, persistent or significant disability/incapacity, or drug dependency/abuse; was life-threatening, an important medical event, or a congenital anomaly/birth defect; or required or prolonged hospitalization.
Outcome measures
| Measure |
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 Participants
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=9 Participants
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 Participants
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=8 Participants
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=9 Participants
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died.
SAEs
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died.
Discontinuations due to AEs
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
2 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Who Died.
Death
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From screening up to Week 12 (treatment period)Population: All treated participants who received at least 1 dose of study therapy.
Clinically significant change in marked laboratory abnormalities (Grade 3 to 4) included: Aspartate aminotransferase (AST)- Grade 3 as \>5.0 to 10.0\*Upper Limit of Normal (ULN), Grade 4 as \>10.0\*ULN; Hemoglobin- Grade 3 as 7.0 to 8.9 g/dL, Grade 4 as \<7.0 g/dL; Neutrophils- Grade 3 as 0.5 to 0.749\*10\^9/L, Grade 4 as \<0.5\*10\^9/L; Lymphocytes- Grade 3 as 0.35 to 0.499\*10\^9/L, Grade 4 as \<0.35\*10\^9/L; Platelets- Grade 3 as 25000 to 49999\*10\^9/L, Grade 4 as \<25000 10\^9/L; white blood cells (WBC) - Grade 3 as 1000 to 1499\*10\^9/L, Grade 4 as \<1000\*10\^9/L and Lipase- Grade 3 as 3.1-5.0\*ULN, Grade 4 as \>5.0\*ULN.
Outcome measures
| Measure |
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 Participants
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=9 Participants
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 Participants
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=8 Participants
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=9 Participants
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
|---|---|---|---|---|---|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities
Hemoglobin
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities
Lymphocytes
|
5 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
3 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities
Neutrophils
|
4 Participants
|
4 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities
Platelets
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities
WBC
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities
AST
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Grade 3 to 4 Laboratory Abnormalities
Lipase
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 participants at risk
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=9 participants at risk
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 participants at risk
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=8 participants at risk
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=9 participants at risk
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
Other adverse events
| Measure |
Placebo+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 participants at risk
Participants received a matching placebo of daclatasvir tablet, orally, once daily (OD) with peginterferon alpha-2a (pegIFNα-2a) subcutaneously once weekly and ribavirin orally, twice daily (BID). Treatment naive participants were those who had never been exposed to any Hepatitis C Virus (HCV) therapy with interferon (IFN) -containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=9 participants at risk
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Treatment Naive)
n=8 participants at risk
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Treatment naive participants were defined as those who had never been exposed to any HCV therapy with IFN- containing regimens including pegIFNα-2a/ ribavirin.
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=8 participants at risk
Participants received 10-mg of daclatasvir OD coadministered with pegIFNα-2a subcutaneously once weekly and ribavirin orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin (Non-Responders)
n=9 participants at risk
Participants received 60-mg of daclatasvir OD coadministered with pegIFNα-2a administered subcutaneously once weekly and ribavirin administered orally BID. Non-responders were participants who had never attained undetectable HCV RNA levels, after at least 12 weeks of the current standard of care pegIFNα-2a/ ribavirin.
|
|---|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal discomfort
|
12.5%
1/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Anal injury
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Infections and infestations
Cystitis
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9
|
|
Gastrointestinal disorders
Diarrhoea
|
37.5%
3/8
|
11.1%
1/9
|
12.5%
1/8
|
12.5%
1/8
|
33.3%
3/9
|
|
Ear and labyrinth disorders
Ear discomfort
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Infections and infestations
Hordeolum
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Psychiatric disorders
Insomnia
|
25.0%
2/8
|
44.4%
4/9
|
37.5%
3/8
|
25.0%
2/8
|
33.3%
3/9
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Muscle rigidity
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
12.5%
1/8
|
11.1%
1/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Eye disorders
Retinopathy
|
12.5%
1/8
|
22.2%
2/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
75.0%
6/8
|
33.3%
3/9
|
62.5%
5/8
|
25.0%
2/8
|
33.3%
3/9
|
|
Investigations
Blood glucose increased
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Choking sensation
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Gastrointestinal disorder
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Heat illness
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Endocrine disorders
Hyperthyroidism
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
General disorders
Influenza like illness
|
25.0%
2/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
General disorders
Injection site haemorrhage
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
25.0%
2/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
2/8
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Seborrhoeic dermatitis
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Stomatitis
|
25.0%
2/8
|
11.1%
1/9
|
12.5%
1/8
|
12.5%
1/8
|
11.1%
1/9
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Anaemia
|
62.5%
5/8
|
66.7%
6/9
|
62.5%
5/8
|
50.0%
4/8
|
55.6%
5/9
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/8
|
22.2%
2/9
|
25.0%
2/8
|
0.00%
0/8
|
11.1%
1/9
|
|
Metabolism and nutrition disorders
Decreased appetite
|
62.5%
5/8
|
22.2%
2/9
|
62.5%
5/8
|
50.0%
4/8
|
44.4%
4/9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/8
|
11.1%
1/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
25.0%
2/8
|
0.00%
0/9
|
|
General disorders
Injection site haematoma
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
General disorders
Injection site reaction
|
12.5%
1/8
|
44.4%
4/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
|
General disorders
Irritability
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Leukopenia
|
37.5%
3/8
|
11.1%
1/9
|
25.0%
2/8
|
25.0%
2/8
|
22.2%
2/9
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
12.5%
1/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
General disorders
Thirst
|
0.00%
0/8
|
0.00%
0/9
|
25.0%
2/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Cardiac disorders
Ventricular extrasystoles
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Investigations
Weight decreased
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9
|
|
Injury, poisoning and procedural complications
Wound
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Investigations
Body temperature decreased
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Eye disorders
Dry eye
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
12.5%
1/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
22.2%
2/9
|
|
Eye disorders
Eyelids pruritus
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
General disorders
Fatigue
|
50.0%
4/8
|
44.4%
4/9
|
25.0%
2/8
|
37.5%
3/8
|
22.2%
2/9
|
|
General disorders
Feeling abnormal
|
0.00%
0/8
|
11.1%
1/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Gingival swelling
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Nervous system disorders
Hypogeusia
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
General disorders
Injection site erythema
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/8
|
12.5%
1/8
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
2/8
|
11.1%
1/9
|
0.00%
0/8
|
25.0%
2/8
|
11.1%
1/9
|
|
Infections and infestations
Onychomycosis
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Infections and infestations
Otitis externa
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
11.1%
1/9
|
|
General disorders
Pyrexia
|
62.5%
5/8
|
66.7%
6/9
|
62.5%
5/8
|
75.0%
6/8
|
88.9%
8/9
|
|
Skin and subcutaneous tissue disorders
Rash
|
37.5%
3/8
|
55.6%
5/9
|
25.0%
2/8
|
0.00%
0/8
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Infections and infestations
Rhinitis
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Sputum retention
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Tongue disorder
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Infections and infestations
Vulvovaginitis
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Abdominal pain upper
|
25.0%
2/8
|
0.00%
0/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/8
|
11.1%
1/9
|
12.5%
1/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
2/8
|
22.2%
2/9
|
25.0%
2/8
|
25.0%
2/8
|
33.3%
3/9
|
|
General disorders
Chills
|
50.0%
4/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9
|
|
Blood and lymphatic system disorders
Lymphopenia
|
62.5%
5/8
|
22.2%
2/9
|
50.0%
4/8
|
62.5%
5/8
|
33.3%
3/9
|
|
General disorders
Malaise
|
62.5%
5/8
|
11.1%
1/9
|
50.0%
4/8
|
25.0%
2/8
|
55.6%
5/9
|
|
Infections and infestations
Oral herpes
|
12.5%
1/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Renal and urinary disorders
Pollakiuria
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
37.5%
3/8
|
33.3%
3/9
|
37.5%
3/8
|
37.5%
3/8
|
11.1%
1/9
|
|
Eye disorders
Retinal haemorrhage
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
37.5%
3/8
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
25.0%
2/8
|
22.2%
2/9
|
12.5%
1/8
|
0.00%
0/8
|
44.4%
4/9
|
|
General disorders
Chest discomfort
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.5%
1/8
|
22.2%
2/9
|
25.0%
2/8
|
12.5%
1/8
|
55.6%
5/9
|
|
Nervous system disorders
Dysgeusia
|
12.5%
1/8
|
22.2%
2/9
|
25.0%
2/8
|
0.00%
0/8
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
25.0%
2/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9
|
|
Blood and lymphatic system disorders
Neutropenia
|
50.0%
4/8
|
44.4%
4/9
|
37.5%
3/8
|
37.5%
3/8
|
22.2%
2/9
|
|
Vascular disorders
Orthostatic hypotension
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Infections and infestations
Pharyngitis
|
25.0%
2/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
General disorders
Temperature intolerance
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9
|
|
Infections and infestations
Tinea pedis
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Tooth loss
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Nervous system disorders
Visual field defect
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
General disorders
Administration site reaction
|
12.5%
1/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Cheilitis
|
37.5%
3/8
|
22.2%
2/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
|
General disorders
Chest pain
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
12.5%
1/8
|
11.1%
1/9
|
|
Skin and subcutaneous tissue disorders
Erythema
|
12.5%
1/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Eye disorders
Eyelid oedema
|
12.5%
1/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Haemorrhoids
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Nervous system disorders
Headache
|
50.0%
4/8
|
33.3%
3/9
|
0.00%
0/8
|
50.0%
4/8
|
44.4%
4/9
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9
|
|
General disorders
Injection site pruritus
|
12.5%
1/8
|
22.2%
2/9
|
0.00%
0/8
|
0.00%
0/8
|
22.2%
2/9
|
|
Musculoskeletal and connective tissue disorders
Muscle haemorrhage
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Infections and infestations
Nasopharyngitis
|
37.5%
3/8
|
11.1%
1/9
|
37.5%
3/8
|
12.5%
1/8
|
11.1%
1/9
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/8
|
0.00%
0/9
|
12.5%
1/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Eye disorders
Conjunctival hyperaemia
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
12.5%
1/8
|
22.2%
2/9
|
|
Nervous system disorders
Dizziness
|
12.5%
1/8
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Eczema
|
25.0%
2/8
|
11.1%
1/9
|
25.0%
2/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Nausea
|
25.0%
2/8
|
22.2%
2/9
|
25.0%
2/8
|
25.0%
2/8
|
22.2%
2/9
|
|
Renal and urinary disorders
Nocturia
|
25.0%
2/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal discomfort
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/8
|
11.1%
1/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
12.5%
1/8
|
0.00%
0/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Eye disorders
Retinal exudates
|
25.0%
2/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
0.00%
0/9
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
0.00%
0/8
|
0.00%
0/9
|
0.00%
0/8
|
0.00%
0/8
|
11.1%
1/9
|
|
Gastrointestinal disorders
Vomiting
|
37.5%
3/8
|
0.00%
0/9
|
0.00%
0/8
|
12.5%
1/8
|
0.00%
0/9
|
Additional Information
BristolMyers Squibb Study Director
Bristol-Myers Squibb International Corporation
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Bristol Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single center publications until after disclosure of the clinical trial's primary publication.
- Publication restrictions are in place
Restriction type: OTHER