Trial Outcomes & Findings for Acthar Gel for Active Systemic Lupus Erythematosus (SLE) (NCT NCT02953821)
NCT ID: NCT02953821
Last Updated: 2020-08-20
Results Overview
PGA is a 100 mm visual analogue scale where higher scores indicate more severe disease activity. Lower scores indicate improvement.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
172 participants
Primary outcome timeframe
Baseline, Week 16, Week 24
Results posted on
2020-08-20
Participant Flow
Of 293 who signed informed consent, 172 were randomized into treatment groups
Participant milestones
| Measure |
Placebo Gel
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
|
Acthar Gel
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
|
|---|---|---|
|
Overall Study
STARTED
|
86
|
86
|
|
Overall Study
Safety Population
|
86
|
86
|
|
Overall Study
Modified Intent to Treat (mITT) Populati
|
85
|
84
|
|
Overall Study
Per Protocol (PP) Population
|
72
|
75
|
|
Overall Study
Completed Week 16 Visit
|
76
|
77
|
|
Overall Study
Completed Study Treatment (Week 24)
|
73
|
76
|
|
Overall Study
COMPLETED
|
71
|
73
|
|
Overall Study
NOT COMPLETED
|
15
|
13
|
Reasons for withdrawal
| Measure |
Placebo Gel
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
|
Acthar Gel
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
4
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Progressive Disease
|
5
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
|
Overall Study
Physician Decision
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
|
Overall Study
Change of address
|
0
|
1
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Out of state for indeterminate time
|
0
|
1
|
|
Overall Study
No improvement
|
0
|
1
|
|
Overall Study
Refused follow-up visit
|
2
|
1
|
Baseline Characteristics
Acthar Gel for Active Systemic Lupus Erythematosus (SLE)
Baseline characteristics by cohort
| Measure |
Placebo Gel
n=86 Participants
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
|
Acthar Gel
n=86 Participants
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.3 years
STANDARD_DEVIATION 12.99 • n=5 Participants
|
40.1 years
STANDARD_DEVIATION 12.45 • n=7 Participants
|
39.7 years
STANDARD_DEVIATION 12.69 • n=5 Participants
|
|
Sex: Female, Male
Female
|
82 Participants
n=5 Participants
|
76 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
30 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
29 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
54 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, Week 16, Week 24Population: mITT population with score at the given week
PGA is a 100 mm visual analogue scale where higher scores indicate more severe disease activity. Lower scores indicate improvement.
Outcome measures
| Measure |
Placebo Gel
n=85 Participants
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
|
Acthar Gel
n=84 Participants
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
|
|---|---|---|
|
Physician's Global Assessment (PGA)
Baseline
|
58.8 score on a scale
Standard Deviation 15.81
|
60.6 score on a scale
Standard Deviation 16.69
|
|
Physician's Global Assessment (PGA)
Week 16
|
33.2 score on a scale
Standard Deviation 18.77
|
30.2 score on a scale
Standard Deviation 14.89
|
|
Physician's Global Assessment (PGA)
Week 24
|
26.9 score on a scale
Standard Deviation 17.76
|
25.5 score on a scale
Standard Deviation 17.22
|
PRIMARY outcome
Timeframe: Baseline, Week 16, Week 24Population: mITT population with a score at the given week
BILAG records disease activity occurring over the past 4 weeks, and is used to determine whether different course of treatment is required. The BILAG-2004 index covers 97 signs/symptoms across 9 organ systems. Each question is answered as 0-not present, 1-improving, 2-same, 3-worse, or 4-new. The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity.
Outcome measures
| Measure |
Placebo Gel
n=85 Participants
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
|
Acthar Gel
n=84 Participants
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
|
|---|---|---|
|
British Isles Lupus Assessment Group 2004 (BILAG 2004)
Week 16
|
9.7 score on a scale
Standard Deviation 6.57
|
7.7 score on a scale
Standard Deviation 5.91
|
|
British Isles Lupus Assessment Group 2004 (BILAG 2004)
Baseline
|
18.2 score on a scale
Standard Deviation 5.15
|
18.0 score on a scale
Standard Deviation 5.45
|
|
British Isles Lupus Assessment Group 2004 (BILAG 2004)
Week 24
|
8.0 score on a scale
Standard Deviation 6.21
|
6.9 score on a scale
Standard Deviation 5.87
|
PRIMARY outcome
Timeframe: Week 16, Week 24Population: modified Intent to Treat (mITT)
The SLEDAI-2K is a modified version of a composite score based on the presence or absence of clinical signs, clinical symptoms, and immunologic laboratory results taken within 10 days of the evaluations. Each of the descriptors has a weighted score and the total score of SLEDAI-2K is the sum of all 24 descriptor scores. The total SLEDAI-2K score falls between 0 and 105, with higher scores representing higher disease activity. Decrease from baseline indicates improvement.
Outcome measures
| Measure |
Placebo Gel
n=85 Participants
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
|
Acthar Gel
n=84 Participants
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
|
|---|---|---|
|
Number of Participants With at Least a 4 Point Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K)
Week 16
|
40 Participants
|
41 Participants
|
|
Number of Participants With at Least a 4 Point Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K)
Week 24
|
46 Participants
|
44 Participants
|
SECONDARY outcome
Timeframe: Week 16Population: mITT population
Among some adults, having a period of SLE symptoms-called flares-may happen every so often, sometimes even years apart, and go away at other times-called remission. The SFI categorizes SLE flares as mild, moderate or severe.
Outcome measures
| Measure |
Placebo Gel
n=85 Participants
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
|
Acthar Gel
n=84 Participants
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
|
|---|---|---|
|
Number of Participants With Severe Flare, Based on the SELENA Flare Index (SFI) at Week 16
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: at Baseline and Weeks 4, 8, and 16Population: mITT population with scores at the given week
The CLASI total activity score reflects ongoing inflammation that can be treated, with points given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Mild, moderate, and severe disease correspond with CLASI activity score ranges of 0 to 9, 10 to 20, and 21 to 70, respectively. Higher scores indicate more disease activity, lower scores indicate improvement.
Outcome measures
| Measure |
Placebo Gel
n=85 Participants
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
|
Acthar Gel
n=84 Participants
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
|
|---|---|---|
|
Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score
Baseline
|
7.1 score on a scale
Standard Deviation 6.53
|
7.9 score on a scale
Standard Deviation 7.48
|
|
Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score
Week 4
|
5.8 score on a scale
Standard Deviation 5.57
|
5.6 score on a scale
Standard Deviation 5.30
|
|
Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score
Week 8
|
5.0 score on a scale
Standard Deviation 5.19
|
5.0 score on a scale
Standard Deviation 5.41
|
|
Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score
Week 12
|
4.5 score on a scale
Standard Deviation 5.41
|
4.0 score on a scale
Standard Deviation 4.08
|
|
Mean Cutaneous Lupus Erythematosus Disease Area and Severity Score- Activity (CLASI) Total Activity Score
Week 16
|
3.8 score on a scale
Standard Deviation 4.36
|
3.4 score on a scale
Standard Deviation 3.77
|
SECONDARY outcome
Timeframe: at Baseline and at Weeks 4, 8, 12 and 16Population: mITT population with tender and swollen joints at the given week
The 28 Joint Count includes assessment of swelling and tenderness in the shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees. The investigator counts how many of the 28 joints are swollen or tender at the given week.
Outcome measures
| Measure |
Placebo Gel
n=28 Joints
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
|
Acthar Gel
n=28 Joints
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
|
|---|---|---|
|
Mean Number of Swollen or Tender Joints on the 28-Joint Count
Baseline
|
7.2 Joints
Standard Deviation 4.98
|
8.2 Joints
Standard Deviation 5.85
|
|
Mean Number of Swollen or Tender Joints on the 28-Joint Count
Week 4
|
4.9 Joints
Standard Deviation 4.77
|
4.2 Joints
Standard Deviation 4.24
|
|
Mean Number of Swollen or Tender Joints on the 28-Joint Count
Week 8
|
3.8 Joints
Standard Deviation 4.97
|
2.9 Joints
Standard Deviation 3.42
|
|
Mean Number of Swollen or Tender Joints on the 28-Joint Count
Week 12
|
2.9 Joints
Standard Deviation 4.40
|
2.3 Joints
Standard Deviation 3.00
|
|
Mean Number of Swollen or Tender Joints on the 28-Joint Count
Week 16
|
2.8 Joints
Standard Deviation 3.67
|
1.9 Joints
Standard Deviation 3.20
|
SECONDARY outcome
Timeframe: Week 20, Week 24Population: mITT Population
Outcome measures
| Measure |
Placebo Gel
n=85 Participants
Participants receive Placebo Gel every other day for 4 weeks, and then twice per week for 20 weeks
Placebo Gel: 1 mL (0 Units) given by a shot under the skin (via subcutaneous injection)
|
Acthar Gel
n=84 Participants
Participants receive Acthar Gel every other day for 4 weeks, and then twice per week for 20 weeks
Acthar Gel: 1 mL (80 Units) given by a shot under the skin (via subcutaneous injection)
|
|---|---|---|
|
Number of Participants With Decrease in Prednisone Dose to < 7.5 mg/Day at Week 20 and Week 24
Week 20
|
5 Participants
|
3 Participants
|
|
Number of Participants With Decrease in Prednisone Dose to < 7.5 mg/Day at Week 20 and Week 24
Week 24
|
6 Participants
|
4 Participants
|
Adverse Events
Placebo Gel
Serious events: 8 serious events
Other events: 23 other events
Deaths: 1 deaths
Acthar Gel
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Gel
n=86 participants at risk
Participants receive Placebo Gel
|
Acthar Gel
n=86 participants at risk
Participants receive Acthar Gel
|
|---|---|---|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.2%
1/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
0.00%
0/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
|
Infections and infestations
Appendicitis
|
1.2%
1/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
0.00%
0/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
|
Infections and infestations
Gastroenteritis
|
1.2%
1/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
0.00%
0/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
1.2%
1/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
|
Infections and infestations
Peritonitis
|
1.2%
1/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
0.00%
0/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
|
Infections and infestations
Pneumonia
|
1.2%
1/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
0.00%
0/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
|
Infections and infestations
Pyelonephritis
|
1.2%
1/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
0.00%
0/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
|
Infections and infestations
Soft tissue infection
|
1.2%
1/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
0.00%
0/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
1.2%
1/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
2.3%
2/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
|
Psychiatric disorders
Drug abuse
|
1.2%
1/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
0.00%
0/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
1.2%
1/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
Other adverse events
| Measure |
Placebo Gel
n=86 participants at risk
Participants receive Placebo Gel
|
Acthar Gel
n=86 participants at risk
Participants receive Acthar Gel
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
7.0%
6/86 • Number of events 6 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
3.5%
3/86 • Number of events 3 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.2%
1/86 • Number of events 1 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
10.5%
9/86 • Number of events 10 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
|
Infections and infestations
Urinary tract infection
|
11.6%
10/86 • Number of events 13 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
7.0%
6/86 • Number of events 6 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
|
Nervous system disorders
Headache
|
5.8%
5/86 • Number of events 6 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
7.0%
6/86 • Number of events 9 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
|
Psychiatric disorders
Insomnia
|
4.7%
4/86 • Number of events 4 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
8.1%
7/86 • Number of events 7 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
|
Vascular disorders
Hypertension
|
0.00%
0/86 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
|
7.0%
6/86 • Number of events 6 • 24 Weeks
A Treatment-Emergent Adverse Event (TEAE) is defined as an undesirable event that begins or worsens after the first dose of study drug and no later than follow up visit date or no more than 28 days after the last dose of study drug if the follow up visit date is missing. TEAEs were collected in the safety population.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place