Trial Outcomes & Findings for Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin) (NCT NCT00874770)
NCT ID: NCT00874770
Last Updated: 2015-10-23
Results Overview
eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
74 participants
Primary outcome timeframe
A Weeks 4 and 12
Results posted on
2015-10-23
Participant Flow
The study was conducted at 14 sites in France and USA.
A total of 74 participants were enrolled, of which 48 were randomized to receive treatment and 26 were not randomized: 22 no longer met study criteria, 2 withdrew consent, 1 was lost to follow-up, and 1 due to other reasons.
Participant milestones
| Measure |
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin
Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin
Participants received 10 mg of daclatasvir OD coadministered with pegIFNα-2a 180 µg given subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin
Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Placebo+pegIFNα-2a+Ribavirin
Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
12
|
12
|
|
Overall Study
COMPLETED
|
7
|
11
|
8
|
7
|
|
Overall Study
NOT COMPLETED
|
5
|
1
|
4
|
5
|
Reasons for withdrawal
| Measure |
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin
Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin
Participants received 10 mg of daclatasvir OD coadministered with pegIFNα-2a 180 µg given subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin
Participants received 60 mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Placebo+pegIFNα-2a+Ribavirin
Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
|---|---|---|---|---|
|
Overall Study
Lack of Efficacy
|
2
|
0
|
0
|
2
|
|
Overall Study
Adverse Event
|
1
|
1
|
4
|
2
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
|
Overall Study
Subject no Longer Meets Study Criteria
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)
Baseline characteristics by cohort
| Measure |
Daclatasvir 3-mg+pegIFNα-2a-2a+Ribavirin
n=12 Participants
Participants received 3 mg of daclatasvir once daily (OD) in coadministration with peginterferon alpha-2a (pegIFNα-2a)180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 10-mg+pegIFNα-2a+Ribavirin
n=12 Participants
Participants received 10-mg of daclatasvir OD in coadministration with pegIFNα-2a-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 60-mg+pegIFNα-2a+Ribavirin
n=12 Participants
Participants received 60-mg of daclatasvir OD in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Placebo+pegIFNα-2a+Ribavirin
n=12 Participants
Participants received a matching placebo of daclatasvir tablets administered orally once daily for 48 weeks in coadministration with pegIFNα-2a 180 µg administered subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 8.56 • n=93 Participants
|
53.2 years
STANDARD_DEVIATION 9.11 • n=4 Participants
|
52 years
STANDARD_DEVIATION 7.34 • n=27 Participants
|
48 years
STANDARD_DEVIATION 10.20 • n=483 Participants
|
51.3 years
STANDARD_DEVIATION 8.80 • n=36 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
5 Participants
n=27 Participants
|
4 Participants
n=483 Participants
|
16 Participants
n=36 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
8 Participants
n=483 Participants
|
32 Participants
n=36 Participants
|
PRIMARY outcome
Timeframe: A Weeks 4 and 12Population: All participants who received at least 1 dose of study drug.
eRVR was defined as undetectable hepatitis C virus RNA less than the lower limit of detection (10 IU/mL) at Weeks 4 and 12.
Outcome measures
| Measure |
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Placebo + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
|---|---|---|---|---|
|
Percentage of Participants With Extended Rapid Virologic Response (eRVR) at Weeks 4 and 12
|
41.7 percentage of participants
|
83.3 percentage of participants
|
75 percentage of participants
|
8.3 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 4Population: All participants who received at least 1 dose of study drug.
RVR was defined as undetectable hepatitis C virus (HCV) RNA ie, HCV RNA less than the lower limit of detection (10 IU/mL) at Week 4.
Outcome measures
| Measure |
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Placebo + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
|---|---|---|---|---|
|
Percentage of Participants With Rapid Virologic Response (RVR) at Week 4
|
41.7 percentage of participants
|
91.7 percentage of participants
|
83.3 percentage of participants
|
8.3 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 12Population: All participants who received at least 1 dose of study drug.
EVR was defined as a ≥2 log10 decrease in hepatitis C virus (HCV) RNA from baseline at Week 12 , or HCV RNA \<10 IU/mL for participants with baseline HCV RNA \<1000 IU/mL.
Outcome measures
| Measure |
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Placebo + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
|---|---|---|---|---|
|
Percentage of Participants With Early Virologic Response (EVR) at Week 12
|
75 percentage of participants
|
100 percentage of participants
|
83.3 percentage of participants
|
66.7 percentage of participants
|
SECONDARY outcome
Timeframe: At Week 12Population: All participants who received at least 1 dose of study drug.
cEVR was defined as hepatitis C virus RNA \<10 IU/mL at Week 12
Outcome measures
| Measure |
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Placebo + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
|---|---|---|---|---|
|
Percentage of Participants With a Complete Early Virologic Response (cEVR) at Week 12
|
58.3 percentage of participants
|
83.3 percentage of participants
|
83.3 percentage of participants
|
41.7 percentage of participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: SAE: From Day 1 up to 30 days after last dose of study drug, AE: From Day 1 to 7 days after last dose of study drugPopulation: All participants who received at least 1 dose of study drug.
An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this 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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.
Outcome measures
| Measure |
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Placebo + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase
SAEs
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase
Discontinuation due to AEs
|
1 participants
|
1 participants
|
4 participants
|
2 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase
Grade 2 to 4 Related AEs
|
6 participants
|
6 participants
|
9 participants
|
7 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Treatment Phase
Deaths
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Day 31 up to Week 24 of post treatment follow-upPopulation: All participants who received at least 1 dose of study drug. n=evaluable patients
An AE was defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a patient or clinical investigation participant administered an investigational (medicinal) product and that does not necessarily have a causal relationship with this 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. Treatment-related AE was defined as an AE that had certain, probable, possible, or unknown relationship to study drug.
Outcome measures
| Measure |
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Placebo + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period
SAEs (n=10,12,12,10)
|
0 participants
|
0 participants
|
3 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period
Discontinuation due to AEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period
Grade 2 to 4 Related AEs
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Serious Adverse Events (SAEs), Discontinuations Due to Adverse Events (AEs), and Treatment-related AEs and Who Died in Follow-up Period
Deaths
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From screening up to Week 12 (treatment period)Population: All participants who received at least 1 dose of study drug. n=evaluable patients at the specified time point
Clinically significant change in marked laboratory abnormalities (Grade 3 to 4 ) included: Alanine aminotransferase (ALT)- Grade 3 as \>5.0 to 10.0\* Upper Limit of Normal (ULN), Grade 4 as \>10.0\*ULN; Aspartate aminotransferase (AST)- Grade 3 as \>5.0 to 10.0\*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; Total Bilirubin- Grade 3 as 2.6-5.0\*ULN, Grade 4 as \>5.0\*ULN; Platelets- Grade 3 as 25000 to 49999\*10\^9/L, Grade 4 as \<25000 10\^9/L and white blood cells (WBC) - Grade 3 as 1000 to 1499\*10\^9/L, Grade 4 as \<1000\*10\^9/L.
Outcome measures
| Measure |
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 3 mg of daclatasvir once daily (OD) coadministered orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 10 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received 60 mg of daclatasvir OD coadministered orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Placebo + pegIFNα-2a + Ribavirin
n=12 Participants
Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
|---|---|---|---|---|
|
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
Hemoglobin (n= 11,12,12,11)
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
Lymphocytes (n= 11,12,12,12)
|
1 participants
|
3 participants
|
3 participants
|
3 participants
|
|
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
Neutrophils (n= 11,12,12,12)
|
2 participants
|
4 participants
|
3 participants
|
4 participants
|
|
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
Platelets (n= 11,12,12,12)
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
ALT (n= 11,12,12,12)
|
0 participants
|
1 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
AST (n= 11,12,12,12)
|
0 participants
|
0 participants
|
0 participants
|
3 participants
|
|
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
Total bilirubin (n= 11,12,12,12)
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Grade 3 to 4 Abnormalities on Laboratory Test Results
WBC (n= 11, 12, 12, 12)
|
0 participants
|
2 participants
|
1 participants
|
2 participants
|
Adverse Events
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin
Serious events: 1 serious events
Other events: 12 other events
Deaths: 0 deaths
Placebo + pegIFNα-2a + Ribavirin
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin
n=12 participants at risk
Participants received 3 mg of daclatasvir once daily (OD) in coadministration orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin
n=12 participants at risk
Participants received 10 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin
n=12 participants at risk
Participants received 60 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Placebo + pegIFNα-2a + Ribavirin
n=12 participants at risk
Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks in with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Bronchitis
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
General disorders
Chest pain
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
Other adverse events
| Measure |
Daclatasvir 3 mg + pegIFNα-2a + Ribavirin
n=12 participants at risk
Participants received 3 mg of daclatasvir once daily (OD) in coadministration orally with peginterferon alpha-2a (pegIFNα-2a)180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 10 mg + pegIFNα-2a + Ribavirin
n=12 participants at risk
Participants received 10 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Daclatasvir 60 mg + pegIFNα-2a + Ribavirin
n=12 participants at risk
Participants received 60 mg of daclatasvir OD in coadministration orally with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
Placebo + pegIFNα-2a + Ribavirin
n=12 participants at risk
Participants received a matching placebo of daclatasvir tablets coadministered orally once daily for 48 weeks in with pegIFNα-2a 180 µg subcutaneously once weekly and ribavirin twice daily (400 mg tablets for participants \<75 kg or 600 mg tablets for participants \>75 kg in the morning with food and 600 mg tablets in the evening with food up to 48 weeks).
|
|---|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
|
Vascular disorders
Blood pressure fluctuation
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Investigations
Blood thyroid stimulating hormone increased
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Metabolism and nutrition disorders
Decreased appetite
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
33.3%
4/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Dysgeusia
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Ear infection
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Genital herpes
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Investigations
Weight decreased
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Abdominal tenderness
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Carbuncle
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Cubital tunnel syndrome
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Dyspepsia
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Vascular disorders
Flushing
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Psychiatric disorders
Food aversion
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
General disorders
Injection site reaction
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Oral herpes
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Tremor
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Upper respiratory tract infection
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Eye disorders
Vision blurred
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Cheilitis
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Dizziness
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Hyperchlorhydria
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Hepatobiliary disorders
Hypertransaminasaemia
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
General disorders
Injection site erythema
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
General disorders
Irritability
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
50.0%
6/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
|
Psychiatric disorders
Libido decreased
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Presyncope
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
41.7%
5/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
33.3%
4/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Skin atrophy
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Syncope
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Vomiting
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
33.3%
4/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
General disorders
Asthenia
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
41.7%
5/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Dermatitis exfoliative
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Eye disorders
Dry eye
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Gastroenteritis
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Hordeolum
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
General disorders
Injection site pain
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Investigations
Liver function test abnormal
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Oral candidiasis
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Periodontal disease
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Stomatitis
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Renal and urinary disorders
Dysuria
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Erythema
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
General disorders
Fatigue
|
50.0%
6/12 • From baseline to 30 days after last dose of drug
|
58.3%
7/12 • From baseline to 30 days after last dose of drug
|
50.0%
6/12 • From baseline to 30 days after last dose of drug
|
75.0%
9/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Gingival disorder
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
General disorders
Influenza like illness
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
50.0%
6/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
33.3%
4/12 • From baseline to 30 days after last dose of drug
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Paraesthesia
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Rash
|
33.3%
4/12 • From baseline to 30 days after last dose of drug
|
33.3%
4/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Tooth infection
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Psychiatric disorders
Agitation
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Body tinea
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Psychiatric disorders
Depressed mood
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Psychiatric disorders
Depression
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
|
Investigations
Electrocardiogram QT prolonged
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Headache
|
75.0%
9/12 • From baseline to 30 days after last dose of drug
|
58.3%
7/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Hyperaesthesia
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
General disorders
Injection site irritation
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Psychiatric disorders
Insomnia
|
33.3%
4/12 • From baseline to 30 days after last dose of drug
|
33.3%
4/12 • From baseline to 30 days after last dose of drug
|
41.7%
5/12 • From baseline to 30 days after last dose of drug
|
50.0%
6/12 • From baseline to 30 days after last dose of drug
|
|
General disorders
Malaise
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Pneumonia
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Poor quality sleep
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Xeroderma
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
33.3%
4/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
|
Psychiatric disorders
Anxiety
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
|
Vascular disorders
Arteriosclerosis
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
General disorders
Chills
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
41.7%
5/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Influenza
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
General disorders
Injection site pruritus
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Psychiatric disorders
Mood swings
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Blood and lymphatic system disorders
Neutropenia
|
33.3%
4/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
41.7%
5/12 • From baseline to 30 days after last dose of drug
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Vascular disorders
Pallor
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Investigations
Prothrombin time prolonged
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
General disorders
Pyrexia
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Tooth abscess
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Investigations
Weight increased
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Ageusia
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Blood and lymphatic system disorders
Anaemia
|
41.7%
5/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
50.0%
6/12 • From baseline to 30 days after last dose of drug
|
41.7%
5/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Bronchitis
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
|
General disorders
Chest pain
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Musculoskeletal and connective tissue disorders
Coccydynia
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Diarrhoea
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Dizziness postural
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Gingival hypertrophy
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Injury, poisoning and procedural complications
Lip injury
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Blood and lymphatic system disorders
Lymphopenia
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Renal and urinary disorders
Micturition urgency
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Gastrointestinal disorders
Nausea
|
33.3%
4/12 • From baseline to 30 days after last dose of drug
|
41.7%
5/12 • From baseline to 30 days after last dose of drug
|
33.3%
4/12 • From baseline to 30 days after last dose of drug
|
50.0%
6/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
General disorders
Pain
|
25.0%
3/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Nervous system disorders
Sinus headache
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Sinusitis
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
16.7%
2/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
|
Infections and infestations
Wound infection
|
8.3%
1/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
0.00%
0/12 • From baseline to 30 days after last dose of drug
|
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