Trial Outcomes & Findings for A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis (NCT NCT02219477)
NCT ID: NCT02219477
Last Updated: 2017-07-11
Results Overview
SVR12, defined as HCV RNA \< lower limit of quantification (LLOQ) in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures. The 95% confidence interval was calculated using the Wilson score method.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
36 participants
Primary outcome timeframe
12 weeks after the last actual dose of study drug
Results posted on
2017-07-11
Participant Flow
Participant milestones
| Measure |
Group 1: GT1B
ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants
|
Group 2: GT1 Non-B
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
|
Group 3: GT4
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
|
|---|---|---|---|
|
Overall Study
STARTED
|
9
|
24
|
3
|
|
Overall Study
COMPLETED
|
9
|
22
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
1
|
Reasons for withdrawal
| Measure |
Group 1: GT1B
ombitasvir/paritaprevir/ritonavir 25/150/100 mg once daily (QD) + dasabuvir 250 mg twice daily (BID) + ribavirin (RBV) for 12 weeks in hepatitis C virus (HCV) genotype (GT) 1b-infected participants
|
Group 2: GT1 Non-B
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
|
Group 3: GT4
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
|
|---|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
0
|
Baseline Characteristics
A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With Ribavirin in Adults With Genotype 1 and Ombitasvir/Paritaprevir/Ritonavir With Ribavirin in Adults With Genotype 4 Chronic Hepatitis C Virus Infection and Decompensated Cirrhosis
Baseline characteristics by cohort
| Measure |
Group 1: GT1B
n=9 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
|
Group 2: GT1 Non-B
n=24 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
|
Group 3: GT4
n=3 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
|
Total
n=36 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Customized
< 65 years
|
7 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
29 Participants
n=4 Participants
|
|
Age, Customized
>= 65 years
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
10 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
26 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after the last actual dose of study drugPopulation: Intent to treat population: all participants who received at least 1 dose of study drug; participants missing data = non-responders. See imputation details in the outcome measure description.
SVR12, defined as HCV RNA \< lower limit of quantification (LLOQ) in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures. The 95% confidence interval was calculated using the Wilson score method.
Outcome measures
| Measure |
Group 1: GT1B
n=9 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
|
Group 2: GT1 Non-B
n=24 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
|
Group 3: GT4
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
|
|---|---|---|---|
|
Percentages of Participants With Sustained Virologic Response 12 Weeks Post-Treatment (SVR12) in Group 1 and in Group 2
|
100 percentage of participants
Interval 70.1 to 100.0
|
95.8 percentage of participants
Interval 79.8 to 99.3
|
—
|
SECONDARY outcome
Timeframe: 12 weeks after the last actual dose of study drugPopulation: Intent to treat population: all participants who received at least 1 dose of study drug; participants missing data = non-responders. See imputation details in the outcome measure description.
SVR12, defined as HCV RNA \< LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. Flanking imputation: for participants with missing HCV RNA at a visit, who have an undetectable HCV RNA or unquantifiable HCV RNA at the preceding visit and the succeeding visit, the missing value was imputed as undetectable or unquantifiable. For SVR analyses, if there was no value in the window after the flanking imputation but there was an HCV RNA value after the window, then it was imputed into the SVR window. After above imputations were applied, if there was still no value in the window but there was an HCV RNA value from a local laboratory present, then it was imputed into the SVR window. Otherwise, participants with missing data were counted as failures.
Outcome measures
| Measure |
Group 1: GT1B
n=3 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
|
Group 2: GT1 Non-B
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
|
Group 3: GT4
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
|
|---|---|---|---|
|
Percentage of Participants With SVR12 in Group 3
|
66.7 percentage of participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeks during treatmentPopulation: Intent to treat population: all participants who received at least 1 dose of study drug.
On-treatment virologic failure was defined as: confirmed HCV RNA ≥ LLOQ after HCV RNA \< LLOQ during treatment; confirmed increase from nadir in HCV RNA (two consecutive HCV RNA measurements \> 1 log˅10 IU/mL above nadir) at any time point during treatment; or HCV RNA ≥ LLOQ persistently during treatment with at least 6 weeks (≥ 36 days) of treatment. The 95% confidence interval was calculated using Wilson score method. SVR12 was defined as HCV RNA \< LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window.
Outcome measures
| Measure |
Group 1: GT1B
n=9 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
|
Group 2: GT1 Non-B
n=24 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
|
Group 3: GT4
n=3 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
|
|---|---|---|---|
|
Percentage of Participants With SVR12 Non-Response Due to Experiencing On-Treatment Virologic Failure
|
0 percentage of participants
Interval 0.0 to 29.9
|
0 percentage of participants
Interval 0.0 to 13.8
|
0 percentage of participants
95% confidence interval was not calculated for Group 3.
|
SECONDARY outcome
Timeframe: Up to 12 weeks after the last actual dose of study drugPopulation: Intent to treat population: all participants who received at least 1 dose of study drug and who had an assessment.
Relapse˅12 was defined as confirmed HCV RNA ≥ LLOQ between end of treatment and 12 weeks after last actual dose of active study drug (up to and including the SVR12 window) for a participant with HCV RNA \< LLOQ at final treatment visit who completes treatment and has post-treatment HCV RNA data. Completion of treatment was defined as a study drug duration ≥ 77 days for participants assigned to 12 weeks of treatment or ≥ 154 days for participants assigned to 24 weeks of treatment. SVR12 was defined as HCV RNA \< LLOQ in the SVR12 window (12 weeks after the last actual dose of study drug) without any confirmed quantifiable (≥ LLOQ) post-treatment value before or during that SVR window. The 95% confidence interval was calculated using the Wilson score method.
Outcome measures
| Measure |
Group 1: GT1B
n=7 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
|
Group 2: GT1 Non-B
n=19 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
|
Group 3: GT4
n=2 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
|
|---|---|---|---|
|
Percentage of Participants With SVR12 Non-Response Due to Experiencing Relapse˅12
|
0 percentage of participants
Interval 0.0 to 35.4
|
0 percentage of participants
Interval 0.0 to 16.8
|
0 percentage of participants
95% confidence interval was not calculated for Group 3.
|
SECONDARY outcome
Timeframe: Up to post-treatment Week 12Population: Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12 for the respective parameter.
Improvement was defined as: * increase of more than 0.2 g/L from baseline to post-treatment Week 12 in albumin * decrease of more than 0.3 µmol/L from baseline to post-treatment Week 12 in bilirubin * decrease of more than 5 ng/mL from baseline to post-treatment Week 12 in alpha-fetoprotein * increase of more than 15\*10\^9/L from baseline to post-treatment Week 12 in platelet count * decrease of more than 0.2 from baseline to post-treatment Week 12 in international normalized ratio.
Outcome measures
| Measure |
Group 1: GT1B
n=9 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
|
Group 2: GT1 Non-B
n=22 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
|
Group 3: GT4
n=2 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
|
|---|---|---|---|
|
Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests
Albumin
|
77.8 percentage of participants
|
77.3 percentage of participants
|
50.0 percentage of participants
|
|
Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests
Bilirubin
|
66.7 percentage of participants
|
72.7 percentage of participants
|
100 percentage of participants
|
|
Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests
Alpha-fetoprotein
|
33.3 percentage of participants
|
—
|
—
|
|
Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests
Platelet count
|
22.2 percentage of participants
|
14.3 percentage of participants
|
0 percentage of participants
|
|
Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Hepatic Function Tests
International normalized ratio
|
0 percentage of participants
|
0 percentage of participants
|
0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to post-treatment Week 12Population: Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12.
The FibroTest score is used to assess liver fibrosis. Scores range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. Improvement was defined as a decrease of more than 0.2 from baseline to post-treatment Week 12.
Outcome measures
| Measure |
Group 1: GT1B
n=9 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
|
Group 2: GT1 Non-B
n=22 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
|
Group 3: GT4
n=2 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
|
|---|---|---|---|
|
Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in FibroTest
|
0 percentage of participants
|
9.1 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to post-treatment Week 12Population: Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12.
The The Child-Pugh score uses five clinical measures of liver disease (3 laboratory parameters and 2 clinical assessments) to measure severity of cirrhosis. Scores range from 5 to 15, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12.
Outcome measures
| Measure |
Group 1: GT1B
n=9 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
|
Group 2: GT1 Non-B
n=22 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
|
Group 3: GT4
n=2 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
|
|---|---|---|---|
|
Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Chld-Pugh Score
|
66.7 percentage of participants
|
54.5 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Up to post-treatment Week 12Population: Intent to treat population: all participants who received at least 1 dose of study drug with values at both baseline and post-treatment Week 12.
MELD is a scoring system for assessing the severity of chronic liver disease. Scores range from 6 to 40, with higher scores indicating more severity. Improvement was defined as a decrease of 1 or more from baseline to post-treatment Week 12.
Outcome measures
| Measure |
Group 1: GT1B
n=8 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
|
Group 2: GT1 Non-B
n=21 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
|
Group 3: GT4
n=2 Participants
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
|
|---|---|---|---|
|
Percentage of Participants With Improvement From Baseline to Post-Treatment Week 12 in Model for End-Stage Liver Disease (MELD) Score
|
87.5 percentage of participants
|
61.9 percentage of participants
|
100 percentage of participants
|
Adverse Events
Group 1: GT1B
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Group 2: GT1 Non-B
Serious events: 10 serious events
Other events: 24 other events
Deaths: 0 deaths
Group 3: GT4
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: GT1B
n=9 participants at risk
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
|
Group 2: GT1 Non-B
n=24 participants at risk
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
|
Group 3: GT4
n=3 participants at risk
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
ASCITES
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
DIARRHOEA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
HAEMATEMESIS
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
HAEMATOCHEZIA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
OESOPHAGEAL VARICES HAEMORRHAGE
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
VOMITING
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
HEPATIC FAILURE
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
PERITONITIS BACTERIAL
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
ACCIDENTAL OVERDOSE
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
POST PROCEDURAL COMPLICATION
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
ELECTROLYTE IMBALANCE
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
HEPATOCELLULAR CARCINOMA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
ANXIETY
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Renal and urinary disorders
RENAL FAILURE
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
Other adverse events
| Measure |
Group 1: GT1B
n=9 participants at risk
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 12 weeks in HCV GT1b-infected participants
|
Group 2: GT1 Non-B
n=24 participants at risk
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + dasabuvir 250 mg BID + RBV for 24 weeks in HCV GT1non-b (including GT1a)-infected participants
|
Group 3: GT4
n=3 participants at risk
ombitasvir/paritaprevir/ritonavir 25/150/100 mg QD + RBV for 24 weeks in HCV GT4-infected participants
|
|---|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
22.2%
2/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
25.0%
6/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Blood and lymphatic system disorders
LEUKOCYTOSIS
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Blood and lymphatic system disorders
PANCYTOPENIA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Cardiac disorders
TACHYCARDIA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
12.5%
3/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
100.0%
3/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
12.5%
3/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
8/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
CONSTIPATION
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
20.8%
5/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
DIARRHOEA
|
33.3%
3/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
41.7%
10/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
FLATULENCE
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
NAUSEA
|
22.2%
2/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
54.2%
13/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
66.7%
2/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
VARICES OESOPHAGEAL
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Gastrointestinal disorders
VOMITING
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
25.0%
6/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
ASTHENIA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
16.7%
4/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
CHILLS
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
FATIGUE
|
33.3%
3/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
45.8%
11/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
66.7%
2/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
OEDEMA PERIPHERAL
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
25.0%
6/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
General disorders
PYREXIA
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
12.5%
3/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
BILE DUCT STENOSIS
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
HYPERBILIRUBINAEMIA
|
22.2%
2/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
12.5%
3/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
JAUNDICE
|
22.2%
2/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Hepatobiliary disorders
OCULAR ICTERUS
|
22.2%
2/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
20.8%
5/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
CYSTITIS
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
DIVERTICULITIS
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
FUNGAL INFECTION
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
GASTROENTERITIS
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
NASOPHARYNGITIS
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
SOFT TISSUE INFECTION
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
STAPHYLOCOCCAL INFECTION
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Infections and infestations
URINARY TRACT INFECTION
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
CONTUSION
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Injury, poisoning and procedural complications
FALL
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
12.5%
3/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
BLOOD CREATININE INCREASED
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
CREATININE RENAL CLEARANCE DECREASED
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
HAEMOGLOBIN DECREASED
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
12.5%
3/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Investigations
WEIGHT INCREASED
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
20.8%
5/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
HYPERKALAEMIA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
HYPERURICAEMIA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
HYPOKALAEMIA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
12.5%
3/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
HYPOMAGNESAEMIA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
12.5%
3/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
29.2%
7/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
FISTULA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
MUSCLE SPASMS
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
25.0%
6/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL CHEST PAIN
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
DIZZINESS
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
29.2%
7/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
66.7%
2/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
HEADACHE
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
20.8%
5/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
HEPATIC ENCEPHALOPATHY
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
16.7%
4/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
HYPERAESTHESIA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
HYPOTONIA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
PARAESTHESIA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
RADIAL NERVE PALSY
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
SYNCOPE
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Nervous system disorders
TREMOR
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
12.5%
3/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
ANXIETY
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
DEPRESSED MOOD
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
INSOMNIA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
25.0%
6/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
66.7%
2/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
IRRITABILITY
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
MOOD SWINGS
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Psychiatric disorders
PANIC ATTACK
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
66.7%
2/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Reproductive system and breast disorders
BREAST PAIN
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Reproductive system and breast disorders
EJACULATION FAILURE
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Reproductive system and breast disorders
ERECTILE DYSFUNCTION
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
33.3%
3/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
4.2%
1/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
29.2%
7/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
PRURITUS GENERALISED
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
RASH
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
29.2%
7/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
33.3%
1/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Skin and subcutaneous tissue disorders
RASH GENERALISED
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
8.3%
2/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Vascular disorders
HYPERTENSION
|
11.1%
1/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
|
Vascular disorders
HYPOTENSION
|
0.00%
0/9 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
12.5%
3/24 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
0.00%
0/3 • Protocol-related treatment-emergent adverse events and treatment-emergent serious adverse events were collected from the first dose of study drug until post treatment Day 30; treatment was up to Week 12 for Group 1, and up to Week 24 for Groups 2 and 3.
A protocol-related event is defined as any event with onset or worsening reported by a participant from the first dose of study drug until 30 days have elapsed following discontinuation of study drug administration. Events were collected whether elicited or spontaneously reported by the participant.
|
Additional Information
Global Medical Services
AbbVie
Phone: 800-633-9110
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- Principal investigator is a sponsor employee AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
- Publication restrictions are in place
Restriction type: OTHER