Trial Outcomes & Findings for Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis (NCT NCT01707472)
NCT ID: NCT01707472
Last Updated: 2019-11-05
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
18 participants
Primary outcome timeframe
First dose date up to Week 24 plus 30 days
Results posted on
2019-11-05
Participant Flow
Participants were enrolled at 1 study site in the United States. The first participant was screened on 04 October 2012. The last study visit occurred on 17 October 2014.
37 participants were screened.
Participant milestones
| Measure |
Simtuzumab in HIV Participants
Participants with human immunodeficiency virus (HIV) received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
Simtuzumab in HCV Participants
Participants with hepatitis C virus (HCV) received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks.
|
Simtuzumab in HIV/HCV Co-Infected Participants
Participants co-infected with HIV and HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
|---|---|---|---|
|
Overall Study
STARTED
|
4
|
6
|
8
|
|
Overall Study
COMPLETED
|
4
|
6
|
8
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Simtuzumab in HIV and/or Hepatitis C- Infected Adults With Liver Fibrosis
Baseline characteristics by cohort
| Measure |
Simtuzumab in HIV Participants
n=4 Participants
Participants with HIV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
Simtuzumab in HCV Participants
n=6 Participants
Participants with HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks.
|
Simtuzumab in HIV/HCV Co-Infected Participants
n=8 Participants
Participants co-infected with HIV and HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
Total
n=18 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
56 years
STANDARD_DEVIATION 6.3 • n=99 Participants
|
58 years
STANDARD_DEVIATION 5.0 • n=107 Participants
|
54 years
STANDARD_DEVIATION 5.6 • n=206 Participants
|
56 years
STANDARD_DEVIATION 5.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
14 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
White
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Ishak Fibrosis Score
Stage 0
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ishak Fibrosis Score
Stage 1
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ishak Fibrosis Score
Stage 2
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Ishak Fibrosis Score
Stage 3
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
|
Ishak Fibrosis Score
Stage 4
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Ishak Fibrosis Score
Stage 5
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
|
Ishak Fibrosis Score
Stage 6
|
2 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
8 Participants
n=7 Participants
|
|
Hepatic Venous Pressure Gradient (HVPG)
|
8 millimeters of Mercury (mm Hg)
STANDARD_DEVIATION 5.3 • n=99 Participants
|
9 millimeters of Mercury (mm Hg)
STANDARD_DEVIATION 3.7 • n=107 Participants
|
8 millimeters of Mercury (mm Hg)
STANDARD_DEVIATION 3.7 • n=206 Participants
|
8 millimeters of Mercury (mm Hg)
STANDARD_DEVIATION 3.8 • n=7 Participants
|
|
Morphometric Quantitative Collagen (MQC)
|
4.24 percentage of MQC
STANDARD_DEVIATION 2.414 • n=99 Participants
|
11.79 percentage of MQC
STANDARD_DEVIATION 9.582 • n=107 Participants
|
12.75 percentage of MQC
STANDARD_DEVIATION 14.596 • n=206 Participants
|
10.54 percentage of MQC
STANDARD_DEVIATION 11.312 • n=7 Participants
|
|
Alpha Smooth Muscle Actin (alpha SMA)
|
6.59 percentage of alpha-SMA
STANDARD_DEVIATION 4.351 • n=99 Participants
|
12.58 percentage of alpha-SMA
STANDARD_DEVIATION 12.184 • n=107 Participants
|
13.32 percentage of alpha-SMA
STANDARD_DEVIATION 15.803 • n=206 Participants
|
11.58 percentage of alpha-SMA
STANDARD_DEVIATION 12.549 • n=7 Participants
|
|
Magnetic Resonance Elastography (MRE)
|
2.19 kPa
STANDARD_DEVIATION 0.370 • n=99 Participants
|
2.01 kPa
STANDARD_DEVIATION 0.322 • n=107 Participants
|
2.32 kPa
STANDARD_DEVIATION 0.487 • n=206 Participants
|
2.20 kPa
STANDARD_DEVIATION 0.399 • n=7 Participants
|
PRIMARY outcome
Timeframe: First dose date up to Week 24 plus 30 daysPopulation: The Safety Analysis Set included participants who received at least one dose of study drug.
Outcome measures
| Measure |
Simtuzumab in HIV Participants
n=4 Participants
Participants with HIV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
Simtuzumab in HCV Participants
n=6 Participants
Participants with HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks.
|
Simtuzumab in HIV/HCV Co-Infected Participants
n=8 Participants
Participants co-infected with HIV and HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
|---|---|---|---|
|
Percentage of Participants Experiencing Treatment-Emergent Adverse Events
|
100 percentage of participants
|
100 percentage of participants
|
100 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set (who were enrolled into the study and received at least 1 dose of study drug) with available data were analyzed.
The Ishak fibrosis score measures the degree of liver fibrosis (scarring) and ranges from 0 (best) to 6 (worst). A negative value in change from baseline indicates an improvement and a positive value indicates worsening.
Outcome measures
| Measure |
Simtuzumab in HIV Participants
n=3 Participants
Participants with HIV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
Simtuzumab in HCV Participants
n=6 Participants
Participants with HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks.
|
Simtuzumab in HIV/HCV Co-Infected Participants
n=8 Participants
Participants co-infected with HIV and HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
|---|---|---|---|
|
Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24
Fibrosis improved: -2
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24
Fibrosis improved: -1
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24
Fibrosis did not change: 0
|
2 Participants
|
4 Participants
|
5 Participants
|
|
Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24
Fibrosis worsened: 1
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants With a Change From Baseline in Ishak Fibrosis Stage Score at Week 24
Fibrosis worsened: 2
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set were analyzed.
Outcome measures
| Measure |
Simtuzumab in HIV Participants
n=4 Participants
Participants with HIV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
Simtuzumab in HCV Participants
n=6 Participants
Participants with HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks.
|
Simtuzumab in HIV/HCV Co-Infected Participants
n=8 Participants
Participants co-infected with HIV and HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
|---|---|---|---|
|
Change From Baseline in HVPG at Week 24
|
2 mm Hg
Standard Deviation 2.4
|
0 mm Hg
Standard Deviation 3.4
|
0 mm Hg
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set with liver biopsy area ≥ 4 mm\^2 (adequate for morphometry measurements) were analyzed.
Outcome measures
| Measure |
Simtuzumab in HIV Participants
n=3 Participants
Participants with HIV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
Simtuzumab in HCV Participants
n=4 Participants
Participants with HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks.
|
Simtuzumab in HIV/HCV Co-Infected Participants
n=5 Participants
Participants co-infected with HIV and HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
|---|---|---|---|
|
Change From Baseline in MQC at Week 24
|
2.07 percentage of MQC
Standard Deviation 5.333
|
-2.54 percentage of MQC
Standard Deviation 11.510
|
1.27 percentage of MQC
Standard Deviation 9.612
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set with liver biopsy area ≥ 4 mm\^2 (adequate for morphometry measurements) were analyzed.
Outcome measures
| Measure |
Simtuzumab in HIV Participants
n=3 Participants
Participants with HIV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
Simtuzumab in HCV Participants
n=4 Participants
Participants with HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks.
|
Simtuzumab in HIV/HCV Co-Infected Participants
n=5 Participants
Participants co-infected with HIV and HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
|---|---|---|---|
|
Change From Baseline in Alpha SMA at Week 24
|
4.69 percentage of alpha-SMA
Standard Deviation 3.938
|
5.27 percentage of alpha-SMA
Standard Deviation 6.973
|
4.50 percentage of alpha-SMA
Standard Deviation 7.669
|
SECONDARY outcome
Timeframe: Baseline; Week 24Population: Participants in the Full Analysis Set with available data were analyzed.
Outcome measures
| Measure |
Simtuzumab in HIV Participants
n=4 Participants
Participants with HIV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
Simtuzumab in HCV Participants
n=3 Participants
Participants with HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks.
|
Simtuzumab in HIV/HCV Co-Infected Participants
n=5 Participants
Participants co-infected with HIV and HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
|---|---|---|---|
|
Change From Baseline in Liver Fibrosis as Estimated by MRE at Week 24
|
0.17 kPa
Standard Deviation 0.141
|
0.09 kPa
Standard Deviation 0.203
|
0.09 kPa
Standard Deviation 0.085
|
Adverse Events
Simtuzumab in HIV Participants
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Simtuzumab in HCV Participants
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Simtuzumab in HIV/HCV Co-Infected Participants
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Simtuzumab in HIV Participants
n=4 participants at risk
Participants with HIV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
Simtuzumab in HCV Participants
n=6 participants at risk
Participants with HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks.
|
Simtuzumab in HIV/HCV Co-Infected Participants
n=8 participants at risk
Participants co-infected with HIV and HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Gallbladder injury
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
Other adverse events
| Measure |
Simtuzumab in HIV Participants
n=4 participants at risk
Participants with HIV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
Simtuzumab in HCV Participants
n=6 participants at risk
Participants with HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks.
|
Simtuzumab in HIV/HCV Co-Infected Participants
n=8 participants at risk
Participants co-infected with HIV and HCV received simtuzumab 700 mg intravenously every 2 weeks over a period of 24 weeks while continuing on standard therapy for HIV.
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hypernatraemia
|
50.0%
2/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
33.3%
2/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypertriglyceridaemia
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
66.7%
4/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
75.0%
6/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Blood and lymphatic system disorders
Lymphocytosis
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Abdominal tenderness
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Glossitis
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
2/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
2/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
General disorders
Fatigue
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
General disorders
Infusion site rash
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
General disorders
Malaise
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
General disorders
Pyrexia
|
75.0%
3/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
75.0%
3/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Influenza
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
2/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Oral candidiasis
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Rhinitis
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
2/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
2/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Alanine aminotransferase increased
|
75.0%
3/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
83.3%
5/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
50.0%
4/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Amylase increased
|
75.0%
3/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
83.3%
5/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
62.5%
5/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Aspartate aminotransferase increased
|
75.0%
3/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
83.3%
5/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
37.5%
3/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Bilirubin conjugated increased
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Blood albumin decreased
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
33.3%
2/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Blood alkaline phosphatase increased
|
75.0%
3/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
33.3%
2/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
37.5%
3/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Blood bilirubin increased
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
2/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Blood creatine phosphokinase abnormal
|
50.0%
2/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
37.5%
3/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine decreased
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Blood creatinine increased
|
50.0%
2/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
2/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Blood lactate dehydrogenase abnormal
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Gamma-glutamyltransferase increased
|
50.0%
2/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
83.3%
5/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
75.0%
6/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
International normalised ratio increased
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
66.7%
4/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
62.5%
5/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Lipase increased
|
50.0%
2/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
50.0%
3/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
50.0%
4/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
Platelet count decreased
|
50.0%
2/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
33.3%
2/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Investigations
White blood cells urine positive
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
2/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
75.0%
3/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
33.3%
2/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
2/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
50.0%
2/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
2/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Lower extremity mass
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Headache
|
50.0%
2/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
2/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Lethargy
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Migraine
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Psychiatric disorders
Depression
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Glycosuria
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Haematuria
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Renal and urinary disorders
Proteinuria
|
50.0%
2/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
25.0%
2/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
12.5%
1/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
16.7%
1/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
25.0%
1/4 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/6 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
0.00%
0/8 • First dose date to Week 24 plus 30 Days
The Safety Analysis Set included participants who received at least one dose of study drug.
|
Additional Information
Gilead Clinical Study Information Center
Gilead Sciences
Phone: 1-833-445-3230 (GILEAD-0)
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met: * The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or * The study has been completed at all study sites for at least 2 years
- Publication restrictions are in place
Restriction type: OTHER