Trial Outcomes & Findings for A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis (NCT NCT00207727)
NCT ID: NCT00207727
Last Updated: 2012-04-23
Results Overview
A newly Gadolinium (Gd) enhancing T1-weighted lesion is defined as a lesion that is enhanced on a current cranial MRI scan but was not classified as a newly Gd enhancing T1-weighted lesion on the previous MRI scan.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
249 participants
Primary outcome timeframe
Week 23
Results posted on
2012-04-23
Participant Flow
A total of 249 patients were enrolled in the trial to receive either placebo or ustekinumab (CNTO 1275). There were 38 investigative sites in North America, Europe and Australia.
Participant milestones
| Measure |
Group I: Placebo
Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
|
Group II: Ustekinumab 27 mg Every 4 Weeks
Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Group III: Ustekinumab 90 mg Every 8 Weeks
Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
|
Group IV: Ustekinumab 90 mg Every 4 Weeks
Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Group V: Ustekinumab 180 mg Every 4 Weeks
Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
49
|
50
|
50
|
50
|
50
|
|
Overall Study
COMPLETED
|
11
|
8
|
9
|
13
|
16
|
|
Overall Study
NOT COMPLETED
|
38
|
42
|
41
|
37
|
34
|
Reasons for withdrawal
| Measure |
Group I: Placebo
Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
|
Group II: Ustekinumab 27 mg Every 4 Weeks
Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Group III: Ustekinumab 90 mg Every 8 Weeks
Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
|
Group IV: Ustekinumab 90 mg Every 4 Weeks
Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Group V: Ustekinumab 180 mg Every 4 Weeks
Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
38
|
41
|
41
|
37
|
33
|
Baseline Characteristics
A Safety and Efficacy Study of CNTO1275 in Patients With Multiple Sclerosis
Baseline characteristics by cohort
| Measure |
Group I: Placebo
n=49 Participants
Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
|
Group II: Ustekinumab 27 mg Every 4 Weeks
n=50 Participants
Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Group III: Ustekinumab 90 mg Every 8 Weeks
n=50 Participants
Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
|
Group IV: Ustekinumab 90 mg Every 4 Weeks
n=50 Participants
Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Group V: Ustekinumab 180 mg Every 4 Weeks
n=50 Participants
Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Total
n=249 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age Continuous
|
36.3 Years
STANDARD_DEVIATION 10.65 • n=5 Participants
|
39.0 Years
STANDARD_DEVIATION 10.34 • n=7 Participants
|
38.6 Years
STANDARD_DEVIATION 11.53 • n=5 Participants
|
39.8 Years
STANDARD_DEVIATION 11.01 • n=4 Participants
|
41.1 Years
STANDARD_DEVIATION 8.34 • n=21 Participants
|
39.0 Years
STANDARD_DEVIATION 10.46 • n=10 Participants
|
|
Sex: Female, Male
Female
|
37 Participants
n=5 Participants
|
32 Participants
n=7 Participants
|
37 Participants
n=5 Participants
|
33 Participants
n=4 Participants
|
36 Participants
n=21 Participants
|
175 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
74 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Week 23Population: Intent to treat. Missing data was imputed. The average number of newly Gd enhancing T1-weighted lesions from all valid visits for the patient will be used when prohibited medications are initiated.
A newly Gadolinium (Gd) enhancing T1-weighted lesion is defined as a lesion that is enhanced on a current cranial MRI scan but was not classified as a newly Gd enhancing T1-weighted lesion on the previous MRI scan.
Outcome measures
| Measure |
Group I: Placebo
n=49 Participants
Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
|
Group II: Ustekinumab 27 mg Every 4 Weeks
n=50 Participants
Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Group III: Ustekinumab 90 mg Every 8 Weeks
n=50 Participants
Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
|
Group IV: Ustekinumab 90 mg Every 4 Weeks
n=50 Participants
Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Group V: Ustekinumab 180 mg Every 4 Weeks
n=50 Participants
Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
|---|---|---|---|---|---|
|
The Cumulative Number of Newly Gadolinium-enhancing T1-weighted Lesions on Cranial Magnetic Resonance Imaging (MRI)s Through Week 23.
|
1.20 Lesions
Interval 0.0 to 9.6
|
1.00 Lesions
Interval 0.0 to 4.0
|
2.00 Lesions
Interval 0.0 to 12.0
|
2.40 Lesions
Interval 0.0 to 7.2
|
2.00 Lesions
Interval 0.0 to 8.0
|
SECONDARY outcome
Timeframe: Week 23Population: Missing data remained missing. No treatment failure rule was implemented.
Clinical relapse of MS is defined as any acute neurological event, reported by the patient, that is characterized by new or worsening signs or symptoms of MS lasting at least 48 hours after a stable period of at least 30 days that is considered, in the judgment of the study physician (treating neurologist), to be a clinical relapse of MS.
Outcome measures
| Measure |
Group I: Placebo
n=49 Participants
Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
|
Group II: Ustekinumab 27 mg Every 4 Weeks
n=50 Participants
Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Group III: Ustekinumab 90 mg Every 8 Weeks
n=50 Participants
Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
|
Group IV: Ustekinumab 90 mg Every 4 Weeks
n=50 Participants
Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Group V: Ustekinumab 180 mg Every 4 Weeks
n=50 Participants
Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
|---|---|---|---|---|---|
|
Relapses of Multiple Sclerosis (MS) Through Week 23
|
0.00 Relapses
Interval 0.0 to 0.0
|
0.00 Relapses
Interval 0.0 to 0.0
|
0.00 Relapses
Interval 0.0 to 1.0
|
0.00 Relapses
Interval 0.0 to 0.0
|
0.00 Relapses
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Baseline, Week 23Population: Intent to treat. Missing data was imputed. Missing EDSS scores was replaced with the last non-missing EDSS value observed (last observation carried forward).
The EDSS is based on an independent neurologist's examination of 8 functional systems and is used to classify multiple sclerosis (MS) severity, progression, disability, and evaluate treatment results. A numeric score ranging from 0 (normal) to 10 (death) is produced, the change from baseline of the EDSS score ranges from -9 to 10.
Outcome measures
| Measure |
Group I: Placebo
n=49 Participants
Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
|
Group II: Ustekinumab 27 mg Every 4 Weeks
n=50 Participants
Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Group III: Ustekinumab 90 mg Every 8 Weeks
n=50 Participants
Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
|
Group IV: Ustekinumab 90 mg Every 4 Weeks
n=50 Participants
Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Group V: Ustekinumab 180 mg Every 4 Weeks
n=50 Participants
Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
|---|---|---|---|---|---|
|
Change From Baseline in Expanded Disability Status Scale (EDSS)
|
0.00 Units on a scale
Interval -0.5 to 0.0
|
0.00 Units on a scale
Interval -0.5 to 0.0
|
0.00 Units on a scale
Interval 0.0 to 0.5
|
0.00 Units on a scale
Interval -0.5 to 0.5
|
0.00 Units on a scale
Interval 0.0 to 0.0
|
Adverse Events
Group I: Placebo
Serious events: 1 serious events
Other events: 31 other events
Deaths: 0 deaths
Group II: Ustekinumab 27 mg Every 4 Weeks
Serious events: 3 serious events
Other events: 35 other events
Deaths: 0 deaths
Group III: Ustekinumab 90 mg Every 8 Weeks
Serious events: 0 serious events
Other events: 34 other events
Deaths: 0 deaths
Group IV: Ustekinumab 90 mg Every 4 Weeks
Serious events: 2 serious events
Other events: 38 other events
Deaths: 0 deaths
Group V: Ustekinumab 180 mg Every 4 Weeks
Serious events: 1 serious events
Other events: 44 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group I: Placebo
n=49 participants at risk
Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
|
Group II: Ustekinumab 27 mg Every 4 Weeks
n=51 participants at risk
Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Group III: Ustekinumab 90 mg Every 8 Weeks
n=47 participants at risk
Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
|
Group IV: Ustekinumab 90 mg Every 4 Weeks
n=52 participants at risk
Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Group V: Ustekinumab 180 mg Every 4 Weeks
n=50 participants at risk
Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
|---|---|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tonsil cancer
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
General disorders
Pain
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
2.0%
1/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Psychiatric disorders
Depression
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
1.9%
1/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
1.9%
1/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
Other adverse events
| Measure |
Group I: Placebo
n=49 participants at risk
Patients received Placebo subcutaneous (SC) injection(s) at Weeks 0, 1, 2, 3, 7, 11, 15, and 19
|
Group II: Ustekinumab 27 mg Every 4 Weeks
n=51 participants at risk
Patients received 27 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Group III: Ustekinumab 90 mg Every 8 Weeks
n=47 participants at risk
Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 11, and 19. Placebo SC injection at Weeks 7 and 15.
|
Group IV: Ustekinumab 90 mg Every 4 Weeks
n=52 participants at risk
Patients received 90 mg ustekinumab SC injection at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
Group V: Ustekinumab 180 mg Every 4 Weeks
n=50 participants at risk
Patients received 180 mg ustekinumab SC injections at Weeks 0, 1, 2, 3, 7, 11, 15, and 19.
|
|---|---|---|---|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
12.2%
6/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
11.8%
6/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
17.0%
8/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
11.5%
6/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
10.0%
5/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Infections and infestations
Nasopharyngitis
|
10.2%
5/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
11.8%
6/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
10.6%
5/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
9.6%
5/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
14.0%
7/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Infections and infestations
Urinary tract infection
|
8.2%
4/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.9%
2/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
4.3%
2/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.8%
2/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
10.0%
5/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Infections and infestations
Viral infection
|
6.1%
3/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.9%
2/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
12.8%
6/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.8%
2/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Infections and infestations
Influenza
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.9%
2/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
4.3%
2/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
9.6%
5/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Infections and infestations
Sinusitis
|
6.1%
3/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
7.8%
4/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
1.9%
1/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
5.9%
3/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.8%
2/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Infections and infestations
Herpes simplex
|
6.1%
3/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
6.4%
3/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
1.9%
1/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Infections and infestations
Rhinitis
|
6.1%
3/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
8.0%
4/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
6.1%
3/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
General disorders
Injection site erythema
|
8.2%
4/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
11.8%
6/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
12.8%
6/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
21.2%
11/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
44.0%
22/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
General disorders
Fatigue
|
2.0%
1/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
15.7%
8/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
12.8%
6/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
11.5%
6/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
12.0%
6/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
General disorders
Injection site pain
|
4.1%
2/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
4.3%
2/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
7.7%
4/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
14.0%
7/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
General disorders
Injection site rash
|
2.0%
1/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
4.3%
2/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
5.8%
3/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
6.0%
3/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
General disorders
Injection site pruritus
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.8%
2/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
10.0%
5/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
General disorders
Injection site bruising
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.8%
2/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
8.0%
4/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
General disorders
Pain
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.1%
1/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
1.9%
1/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
6.0%
3/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
General disorders
Pyrexia
|
6.1%
3/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.8%
2/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
General disorders
Chills
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
5.8%
3/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Nervous system disorders
Headache
|
4.1%
2/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
13.7%
7/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
10.6%
5/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
17.3%
9/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
14.0%
7/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Nervous system disorders
Dizziness
|
2.0%
1/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.9%
2/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
6.4%
3/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.8%
2/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Nervous system disorders
Hypoaesthesia
|
6.1%
3/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.9%
2/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
6.4%
3/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
1.9%
1/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
4.0%
2/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Nervous system disorders
Paraesthesia
|
8.2%
4/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
4.3%
2/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.8%
2/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
8.5%
4/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
5.8%
3/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
8.0%
4/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
7.8%
4/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.1%
1/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
5.8%
3/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
4.0%
2/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
5.9%
3/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.1%
1/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.8%
2/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.1%
3/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
1.9%
1/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
8.0%
4/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.1%
3/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.9%
2/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
4.3%
2/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
1.9%
1/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Musculoskeletal and connective tissue disorders
Shoulder pain
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
5.9%
3/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
4.3%
2/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
1.9%
1/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Gastrointestinal disorders
Nausea
|
10.2%
5/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
4.3%
2/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
7.7%
4/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
12.0%
6/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Gastrointestinal disorders
Diarrhoea
|
2.0%
1/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
5.9%
3/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
4.3%
2/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
1.9%
1/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
6.0%
3/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
7.8%
4/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
4.3%
2/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
1.9%
1/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
2.0%
1/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.9%
2/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
4.3%
2/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
7.7%
4/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
8.0%
4/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
3/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
9.8%
5/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
4.3%
2/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
5.8%
3/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Psychiatric disorders
Depression
|
10.2%
5/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.9%
2/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
4.3%
2/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
7.7%
4/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
4.0%
2/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Psychiatric disorders
Insomnia
|
2.0%
1/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.9%
2/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.1%
1/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
1.9%
1/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
6.0%
3/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.9%
2/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.1%
1/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
7.7%
4/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
6.0%
3/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Eye disorders
Vision blurred
|
6.1%
3/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
3.8%
2/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
6.0%
3/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Eye disorders
Eye pain
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.1%
1/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
6.0%
3/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Injury, poisoning and procedural complications
Contusion
|
2.0%
1/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
10.0%
5/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Injury, poisoning and procedural complications
Skin laceration
|
4.1%
2/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
6.0%
3/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.1%
1/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
1.9%
1/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
6.0%
3/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
|
Vascular disorders
Hypertension
|
2.0%
1/49 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
0.00%
0/51 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.1%
1/47 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
5.8%
3/52 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
2.0%
1/50 • 71 weeks
Number of participants in each of the 5 dosage groups in the "Participant Flow" rows is different from number of participants analyzed for safety as the actual dosage of medication received by participants in the 5 groups was different due to unavailability of the study medication
|
Additional Information
Sr. Dir. Clinical Research
Centocor Research & Development, Inc.
Phone: 1-800-457-6399
Results disclosure agreements
- Principal investigator is a sponsor employee Generally, the only disclosure restriction on the PI is that the sponsor has 60 days to review results communications prior to public release and can embargo communications regarding trial results for a period that does not exceed 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER