Trial Outcomes & Findings for A Study of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis. (NCT NCT00425438)
NCT ID: NCT00425438
Last Updated: 2014-09-25
Results Overview
CR was defined as a urinary protein value of less than (\<) 500 mg per 24 hours (mg/24h) and no hematuria or cellular casts in the urine, and a stable serum creatinine value within the range of plus or minus (±) 25 percent (%) of baseline (BL) or some improvement.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
52 participants
Primary outcome timeframe
Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48
Results posted on
2014-09-25
Participant Flow
Participant milestones
| Measure |
Mycophenolate Mofetil
Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
|
Cyclophosphamide, Azathioprine
Participants received cyclophosphamide 0.75 grams per square meter (g/m\^2), intravenously (IV), every 4 weeks from Weeks 1 through 4, and 0.5 to (-) 1.0 g/m\^2, IV, to maintain a minimum white blood cell (WBC) count of greater than or equal to (≥) 2500 per cubic millimeter (/mm\^3) every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
27
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
25
|
27
|
Reasons for withdrawal
| Measure |
Mycophenolate Mofetil
Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
|
Cyclophosphamide, Azathioprine
Participants received cyclophosphamide 0.75 grams per square meter (g/m\^2), intravenously (IV), every 4 weeks from Weeks 1 through 4, and 0.5 to (-) 1.0 g/m\^2, IV, to maintain a minimum white blood cell (WBC) count of greater than or equal to (≥) 2500 per cubic millimeter (/mm\^3) every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
|
|---|---|---|
|
Overall Study
Termination by Sponsor
|
25
|
27
|
Baseline Characteristics
A Study of CellCept (Mycophenolate Mofetil) in Patients With Lupus Nephritis.
Baseline characteristics by cohort
| Measure |
Mycophenolate Mofetil
n=25 Participants
Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
|
Cyclophosphamide, Azathioprine
n=27 Participants
Participants received cyclophosphamide 0.75 g/m\^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m\^2, IV, to maintain a minimum WBC count of 2500/mm\^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.4 years
STANDARD_DEVIATION 9.8 • n=93 Participants
|
31.6 years
STANDARD_DEVIATION 8.0 • n=4 Participants
|
32.4 years
STANDARD_DEVIATION 8.9 • n=27 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
23 Participants
n=4 Participants
|
45 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48Population: Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.
CR was defined as a urinary protein value of less than (\<) 500 mg per 24 hours (mg/24h) and no hematuria or cellular casts in the urine, and a stable serum creatinine value within the range of plus or minus (±) 25 percent (%) of baseline (BL) or some improvement.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48Population: Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.
The median time, in months, to CR was defined as the time from randomization to CR event.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48Population: Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.
Treatment response was defined by a reduction in the ratio of urine protein to creatinine to \<3 mg/mg for participants with nephrotic proteinuria and a decrease of more than 50% in their urine protein to creatinine value from BL for participants with non-nephrotic proteinuria; a stable serum creatinine value or an increase of more than 30% from BL; and having not received IV prednisone after Week 28.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48Population: Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.
GFR was calculated according to the simplified modification of diet in renal disease (MDRD) formula.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48Population: Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48Population: Efficacy data were not analyzed because of study termination. The study was terminated early for administrative reasons and no participants completed all planned study visits; therefore efficacy analyses could not be performed.
Treatment failure was defined as the occurrence of any of the following: death; chronic renal failure requiring dialysis or kidney transplantation; an increase in average serum creatinine values by 2-fold for 2 consecutive measures from BL, and a increase by 2-fold for 2 consecutive measures in at least 4 weeks; recurrent kidney disease defined by, proteinuria, a doubling in the ratio of urine protein to creatinine from BL and a urinary protein value of \<0.5 g/24h or greater than (\>) 1 g/24h or \>0.5 g/24h or \>2 g/24h at Week 24, kidney disease, defined by an increase in serum creatinine of 25% from BL along with a doubling of urinary protein of at least 2 g/24h, and hematuria, 2 or more blood cells per urine dipstick test.
Outcome measures
Outcome data not reported
Adverse Events
Mycophenolate Mofetil
Serious events: 8 serious events
Other events: 13 other events
Deaths: 0 deaths
Cyclophosphamide, Azathioprine
Serious events: 5 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Mycophenolate Mofetil
n=25 participants at risk
Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
|
Cyclophosphamide, Azathioprine
n=27 participants at risk
Participants received cyclophosphamide 0.75 g/m\^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m\^2, IV, to maintain a minimum WBC count of 2500/mm\^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
|
|---|---|---|
|
Infections and infestations
Lung infection
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
7.4%
2/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
General disorders
Pyrexia
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Gastrointestinal disorders
Gastroenteritis
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Gastrointestinal disorders
Nausea
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Gastrointestinal disorders
Vomiting
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Infections and infestations
Infection
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Renal and urinary disorders
Acute renal failure
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Herpes zoster
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Surgical and medical procedures
Hospitalization
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
Other adverse events
| Measure |
Mycophenolate Mofetil
n=25 participants at risk
Participants received mycophenolate mofetil (MMF) 0.5 grams (g), orally (PO), twice daily (BID) from Day 0 to the end of Week 1, followed by 1.0 g, PO, BID from Weeks 2 through 24, and 0.75 g, PO, BID up to 48 weeks after Week 24. Participants also received prednisolone 0.75 to 1.0 milligrams per kilogram (mg/kg), PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
|
Cyclophosphamide, Azathioprine
n=27 participants at risk
Participants received cyclophosphamide 0.75 g/m\^2, IV, every 4 weeks from Weeks 1 through 4, and 0.5-1.0 g/m\^2, IV, to maintain a minimum WBC count of 2500/mm\^3 every 4 weeks from Weeks 5 through 24. Participants also received azathioprine 100 mg, PO, daily for participants with a body weight of 50 to 70 kg and 150 mg, PO, daily for participants with a body weight of more than 70 kg from Weeks 25 through 48. Participants also received prednisolone 0.75 to 1.0 mg/kg, PO, once per day, up to a maximum of 60 mg per day from Weeks 1 through 4, reduced by 10 mg per day every 2 weeks until dose reached 40 mg/day, followed by a reduction of 5 mg/day every 2 weeks until dose reached 10 mg per day up to Week 48.
|
|---|---|---|
|
Cardiac disorders
Oedema peripheral
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
11.1%
3/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Cardiac disorders
Sinus tachycardia
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Cardiac disorders
Tachycardia
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Ear and labyrinth disorders
Hypoacusis
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Eye disorders
Vision blurred
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Gastrointestinal disorders
Abdominal distension
|
8.0%
2/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Gastrointestinal disorders
Gingival bleeding
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Gastrointestinal disorders
Mouth ulceration
|
8.0%
2/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Gastrointestinal disorders
Nausea
|
8.0%
2/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
14.8%
4/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Gastrointestinal disorders
Dyschezia
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
General disorders
Asthenia
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
General disorders
Local swelling
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
General disorders
Pyrexia
|
12.0%
3/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Hepatobiliary disorders
Liver disorder
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Infections and infestations
Gastroenteritis
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Infections and infestations
Infection
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Infections and infestations
Nasopharyngitis
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Infections and infestations
Otitis media
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
11.1%
3/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
7.4%
2/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
11.1%
3/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Blood glucose increased
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
7.4%
2/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Platelet count decreased
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
Weight increased
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Investigations
White blood cell count decreased
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Hyperuricemia
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
7.4%
2/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Nervous system disorders
Poor quality sleep
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Renal and urinary disorders
Urinary tract infection
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Reproductive system and breast disorders
Menstrual disorder
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
12.0%
3/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Respiratory, thoracic and mediastinal disorders
Sputum decreased
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Acne
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Eyelid oedema
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Vascular disorders
Venous thrombosis limb
|
4.0%
1/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
0.00%
0/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/25 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
3.7%
1/27 • Screening, Day 0, Weeks 2, 4, 8, 12, 16, 20, 24, 32, 40, and 48.
All participants who received at least 1 dose of study treatment were included in the safety analysis population.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER