Trial Outcomes & Findings for A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus (NCT NCT02504645)
NCT ID: NCT02504645
Last Updated: 2019-04-11
Results Overview
A Systemic lupus erythematosus Responder Index (SRI) response is defined as a reduction from baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of at least 4 points, no worsening in Physician's Global Assessment (PhGA) (with worsening defined as an increase in PhGA of more than 0.30 point from baseline), no new British Isles Lupus Assessment Group A (BILAG A) body system score, and no more than 1 new BILAG B body system score from baseline. The decrease of 4 points of the SRI is considered as better ouctome.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
202 participants
Primary outcome timeframe
At week 52
Results posted on
2019-04-11
Participant Flow
200 patients were planned to be enrolled and treated. At the end, 202 were treated.
Participant milestones
| Measure |
IPP-201101 200-mcg Plus SOC
Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
IPP-201101
Standard of Care
|
PLACEBO Plus SOC
Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
Placebo
Standard of Care
|
|---|---|---|
|
Overall Study
STARTED
|
101
|
101
|
|
Overall Study
COMPLETED
|
77
|
76
|
|
Overall Study
NOT COMPLETED
|
24
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A 52-Week, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of a 200-mcg Dose of IPP-201101 Plus Standard of Care in Patients With Systemic Lupus Erythematosus
Baseline characteristics by cohort
| Measure |
IPP-201101 200-mcg Plus SOC
n=101 Participants
Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
IPP-201101
Standard of Care
|
PLACEBO Plus SOC
n=101 Participants
Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
Placebo
Standard of Care
|
Total
n=202 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
101 Participants
n=5 Participants
|
101 Participants
n=7 Participants
|
202 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=5 Participants
|
92 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
88 Participants
n=5 Participants
|
84 Participants
n=7 Participants
|
172 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
13 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
Hungary
|
9 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
36 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
73 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
10 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
12 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
Mauritius
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At week 52Population: All patients who received at least one study drug.
A Systemic lupus erythematosus Responder Index (SRI) response is defined as a reduction from baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score of at least 4 points, no worsening in Physician's Global Assessment (PhGA) (with worsening defined as an increase in PhGA of more than 0.30 point from baseline), no new British Isles Lupus Assessment Group A (BILAG A) body system score, and no more than 1 new BILAG B body system score from baseline. The decrease of 4 points of the SRI is considered as better ouctome.
Outcome measures
| Measure |
IPP-201101 200-mcg Plus SOC
n=101 Participants
Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
IPP-201101
Standard of Care
|
PLACEBO Plus SOC
n=101 Participants
Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
Placebo
Standard of Care
|
|---|---|---|
|
Assessment of Systemic Lupus Erythematosus Responder Index (SRI) at Week 52
|
52.5 percentage of patient responder
|
44.6 percentage of patient responder
|
POST_HOC outcome
Timeframe: At week 52Population: All EU patients who had an assessment of "Yes" for anti-dsDNA at randomization
EU patients who had an assessment of "Yes" for anti-dsDNA at randomization and responders at week 52
Outcome measures
| Measure |
IPP-201101 200-mcg Plus SOC
n=52 Participants
Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
IPP-201101
Standard of Care
|
PLACEBO Plus SOC
n=55 Participants
Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
Placebo
Standard of Care
|
|---|---|---|
|
Proportion of Responders of EU Patients Having Anti-dsDNA ar Randomization
|
61.5 percentage of patient responder
|
47.3 percentage of patient responder
|
Adverse Events
IPP-201101 200-mcg Plus SOC
Serious events: 13 serious events
Other events: 94 other events
Deaths: 0 deaths
PLACEBO Plus SOC
Serious events: 16 serious events
Other events: 96 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
IPP-201101 200-mcg Plus SOC
n=101 participants at risk
Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
IPP-201101
Standard of Care
|
PLACEBO Plus SOC
n=101 participants at risk
Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
Placebo
Standard of Care
|
|---|---|---|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Vascular disorders
Hypertension
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
2.0%
2/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mesothelioma malignant
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
3.0%
3/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
General disorders
face Edema
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Psychiatric disorders
depression
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Reproductive system and breast disorders
Pelvic fluid collection
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Reproductive system and breast disorders
uterine hemorrhage
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Injury, poisoning and procedural complications
Subdural Hematoma
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Cardiac disorders
Acute myocardial infarction
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Cardiac disorders
Myocarditis
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
2/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Nervous system disorders
Cerebrovascular accident
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Nervous system disorders
Hypoesthesia
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Nervous system disorders
Migraine
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Nervous system disorders
Syncope
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Nervous system disorders
Tension Headache
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Hepatobiliary disorders
Cholecystitis
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Renal and urinary disorders
Renal failure
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Butterfly rash
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Cutaneous lupus erythematosus
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
2.0%
2/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Infections and infestations
gastroenteritis
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Infections and infestations
Kidney infection
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Infections and infestations
Lower respiratory Tract Infection
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Infections and infestations
Pneumonia
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
Other adverse events
| Measure |
IPP-201101 200-mcg Plus SOC
n=101 participants at risk
Patients randomly assigned to IPP-201101 will be administered a dosage of 200 mcg subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
IPP-201101
Standard of Care
|
PLACEBO Plus SOC
n=101 participants at risk
Patients randomly assigned to placebo will be administered placebo subcutaneously (sc) every 4 weeks for 48 weeks (a total of 13 doses will be administered).
Placebo
Standard of Care
|
|---|---|---|
|
Nervous system disorders
Headache
|
11.9%
12/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
16.8%
17/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Nervous system disorders
Migraine
|
5.0%
5/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
General disorders
Injection site erythema
|
5.0%
5/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.00%
0/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
General disorders
Mucosal ulceration
|
4.0%
4/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
7.9%
8/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
General disorders
Pyrexia
|
5.0%
5/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
5.0%
5/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Ear and labyrinth disorders
Vertigo
|
5.9%
6/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
6.9%
7/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Gastrointestinal disorders
Nausea
|
5.9%
6/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
2.0%
2/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Renal and urinary disorders
proteinuria
|
3.0%
3/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
5.9%
6/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
11.9%
12/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
12.9%
13/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Skin and subcutaneous tissue disorders
Rash
|
11.9%
12/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
7.9%
8/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.9%
12/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
12.9%
13/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
14.9%
15/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
13.9%
14/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.9%
9/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
8.9%
9/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.9%
6/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
0.99%
1/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
2.0%
2/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
9.9%
10/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Infections and infestations
Bronchitis
|
6.9%
7/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
7.9%
8/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Infections and infestations
Nasopharyngitis
|
7.9%
8/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
6.9%
7/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Infections and infestations
Pharyngitis
|
2.0%
2/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
5.0%
5/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Infections and infestations
Upper respiratory tract infection
|
19.8%
20/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
27.7%
28/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Infections and infestations
Urinary tract infection
|
22.8%
23/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
9.9%
10/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Vascular disorders
Hypertension
|
3.0%
3/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
6.9%
7/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
3.0%
3/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
5.9%
6/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
|
Respiratory, thoracic and mediastinal disorders
Leukopenia
|
7.9%
8/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
6.9%
7/101 • Adverse event collection was done during 52 weeks for each patient.
The definitions met the clinicaltrials.gov definitions
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60