Trial Outcomes & Findings for Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects (NCT NCT01865552)
NCT ID: NCT01865552
Last Updated: 2019-06-04
Results Overview
pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
138 participants
Primary outcome timeframe
0 to 480 hours post-dose
Results posted on
2019-06-04
Participant Flow
Participant milestones
| Measure |
SB4 and EU Sourced Enbrel in Part A
SB4 (Period 1) followed by EU sourced Enbrel (Period 2)
SB4: SC administration
EU sourced Enbrel: SC administration
|
EU Sourced Enbrel and SB4 in Part A
EU sourced Enbrel (Period 1) followed by SB4 (Period 2)
SB4: SC administration
EU sourced Enbrel: SC administration
|
SB4 and US Sourced Enbrel in Part B
SB4 (Period 1) followed by US sourced Enbrel (Period 2)
SB4: SC administration
US sourced Enbrel: SC administration
|
US Sourced Enbrel and SB4 in Part B
US sourced Enbrel (Period 1) followed by SB4 (Period 2)
SB4: SC administration
US sourced Enbrel: SC administration
|
EU and US Sourced Enbrel in Part C
EU sourced Enbrel (Period 1) followed by US sourced Enbrel (Period 2)
EU sourced Enbrel: SC administration
US sourced Enbrel: SC administration
|
US and EU Sourced Enbrel in Part C
US sourced Enbrel (Period 1) followed by EU sourced Enbrel (Period 2)
EU sourced Enbrel: SC administration
US sourced Enbrel: SC administration
|
|---|---|---|---|---|---|---|
|
Period 1
STARTED
|
23
|
23
|
23
|
23
|
23
|
23
|
|
Period 1
Discontinued From Period 1
|
1
|
0
|
0
|
1
|
3
|
1
|
|
Period 1
COMPLETED
|
22
|
23
|
23
|
22
|
20
|
22
|
|
Period 1
NOT COMPLETED
|
1
|
0
|
0
|
1
|
3
|
1
|
|
Period 2
STARTED
|
22
|
23
|
23
|
22
|
20
|
22
|
|
Period 2
COMPLETED
|
22
|
23
|
23
|
22
|
20
|
22
|
|
Period 2
NOT COMPLETED
|
0
|
0
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
| Measure |
SB4 and EU Sourced Enbrel in Part A
SB4 (Period 1) followed by EU sourced Enbrel (Period 2)
SB4: SC administration
EU sourced Enbrel: SC administration
|
EU Sourced Enbrel and SB4 in Part A
EU sourced Enbrel (Period 1) followed by SB4 (Period 2)
SB4: SC administration
EU sourced Enbrel: SC administration
|
SB4 and US Sourced Enbrel in Part B
SB4 (Period 1) followed by US sourced Enbrel (Period 2)
SB4: SC administration
US sourced Enbrel: SC administration
|
US Sourced Enbrel and SB4 in Part B
US sourced Enbrel (Period 1) followed by SB4 (Period 2)
SB4: SC administration
US sourced Enbrel: SC administration
|
EU and US Sourced Enbrel in Part C
EU sourced Enbrel (Period 1) followed by US sourced Enbrel (Period 2)
EU sourced Enbrel: SC administration
US sourced Enbrel: SC administration
|
US and EU Sourced Enbrel in Part C
US sourced Enbrel (Period 1) followed by EU sourced Enbrel (Period 2)
EU sourced Enbrel: SC administration
US sourced Enbrel: SC administration
|
|---|---|---|---|---|---|---|
|
Period 1
Adverse Event
|
1
|
0
|
0
|
1
|
1
|
1
|
|
Period 1
Pathological lab
|
0
|
0
|
0
|
0
|
1
|
0
|
|
Period 1
Other
|
0
|
0
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Pharmacokinetic, Safety, Tolerability and Immunogenicity Study of SB4 in Healthy Male Subjects
Baseline characteristics by cohort
| Measure |
SB4 and EU Sourced Enbrel in Part A
n=23 Participants
SB4 followed by EU sourced Enbrel
SB4: SC administration
EU sourced Enbrel: SC administration
|
EU Sourced Enbrel and SB4 in Part A
n=23 Participants
EU sourced Enbrel followed by SB4
SB4: SC administration
EU sourced Enbrel: SC administration
|
SB4 and US Sourced Enbrel in Part B
n=23 Participants
SB4 followed by US sourced Enbrel
SB4: SC administration
US sourced Enbrel: SC administration
|
US Sourced Enbrel and SB4 in Part B
n=23 Participants
US sourced Enbrel followed by SB4
SB4: SC administration
US sourced Enbrel: SC administration
|
EU and US Sourced Enbrel in Part C
n=23 Participants
EU sourced Enbrel followed by US sourced Enbrel
EU sourced Enbrel: SC administration
US sourced Enbrel: SC administration
|
US and EU Sourced Enbrel in Part C
n=23 Participants
US sourced Enbrel followed by EU sourced Enbrel
EU sourced Enbrel: SC administration
US sourced Enbrel: SC administration
|
Total
n=138 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
38 years
STANDARD_DEVIATION 9.4 • n=5 Participants
|
41 years
STANDARD_DEVIATION 10.9 • n=7 Participants
|
38 years
STANDARD_DEVIATION 9.7 • n=5 Participants
|
43 years
STANDARD_DEVIATION 8.9 • n=4 Participants
|
40 years
STANDARD_DEVIATION 10.5 • n=21 Participants
|
41 years
STANDARD_DEVIATION 9.4 • n=8 Participants
|
40 years
STANDARD_DEVIATION 9.8 • n=8 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
23 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
23 Participants
n=8 Participants
|
138 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 0 to 480 hours post-dosePopulation: Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.
pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Outcome measures
| Measure |
SB4 in Part A
n=42 Participants
SB4: SC administration
|
EU Sourced Enbrel in Part A
n=42 Participants
EU sourced Enbrel: SC administration
|
SB4 in Part B
n=44 Participants
SB4: SC administration
|
US Sourced Enbrel in Part B
n=44 Participants
US sourced Enbrel: SC administration
|
EU Sourced Enbrel in Part C
n=42 Participants
EU sourced Enbrel: SC administration
|
US Sourced Enbrel in Part C
n=42 Participants
US sourced Enbrel: SC administration
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to Infinity (AUCinf)
|
769.069 µg·h/mL
Standard Deviation 243.9039
|
771.680 µg·h/mL
Standard Deviation 226.2874
|
834.680 µg·h/mL
Standard Deviation 242.7652
|
810.054 µg·h/mL
Standard Deviation 195.9770
|
790.110 µg·h/mL
Standard Deviation 274.2535
|
768.228 µg·h/mL
Standard Deviation 238.1251
|
PRIMARY outcome
Timeframe: 0 to 480 hours post-dosePopulation: Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.
pre-dose (0 h) and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose.
Outcome measures
| Measure |
SB4 in Part A
n=42 Participants
SB4: SC administration
|
EU Sourced Enbrel in Part A
n=42 Participants
EU sourced Enbrel: SC administration
|
SB4 in Part B
n=44 Participants
SB4: SC administration
|
US Sourced Enbrel in Part B
n=44 Participants
US sourced Enbrel: SC administration
|
EU Sourced Enbrel in Part C
n=42 Participants
EU sourced Enbrel: SC administration
|
US Sourced Enbrel in Part C
n=42 Participants
US sourced Enbrel: SC administration
|
|---|---|---|---|---|---|---|
|
Maximum Serum Concentration (Cmax)
|
3.607 μg/mL
Standard Deviation 1.4298
|
3.435 μg/mL
Standard Deviation 1.2390
|
3.869 μg/mL
Standard Deviation 1.3251
|
3.613 μg/mL
Standard Deviation 1.0252
|
3.720 μg/mL
Standard Deviation 1.5444
|
3.575 μg/mL
Standard Deviation 1.4833
|
SECONDARY outcome
Timeframe: 0 to 480 hours post-dosePopulation: Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.
pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Outcome measures
| Measure |
SB4 in Part A
n=42 Participants
SB4: SC administration
|
EU Sourced Enbrel in Part A
n=42 Participants
EU sourced Enbrel: SC administration
|
SB4 in Part B
n=44 Participants
SB4: SC administration
|
US Sourced Enbrel in Part B
n=44 Participants
US sourced Enbrel: SC administration
|
EU Sourced Enbrel in Part C
n=42 Participants
EU sourced Enbrel: SC administration
|
US Sourced Enbrel in Part C
n=42 Participants
US sourced Enbrel: SC administration
|
|---|---|---|---|---|---|---|
|
Area Under the Concentration-time Curve From Time Zero to the Last Quantifiable Concentration (AUClast)
|
728.169 µg·h/mL
Standard Deviation 234.7621
|
734.015 µg·h/mL
Standard Deviation 220.2722
|
788.773 µg·h/mL
Standard Deviation 232.4636
|
765.187 µg·h/mL
Standard Deviation 184.5046
|
752.277 µg·h/mL
Standard Deviation 259.2088
|
727.820 µg·h/mL
Standard Deviation 229.8597
|
SECONDARY outcome
Timeframe: 0 to 480 hours post-dosePopulation: Overall number of participans Analyzed equals to number of subjects who contributed to summary statistics.
pre-dose and at 6, 12, 24, 36, 48, 60, 72, 84, 96, 120, 144, 168, 216, 312 and 480 h post-dose
Outcome measures
| Measure |
SB4 in Part A
n=42 Participants
SB4: SC administration
|
EU Sourced Enbrel in Part A
n=42 Participants
EU sourced Enbrel: SC administration
|
SB4 in Part B
n=44 Participants
SB4: SC administration
|
US Sourced Enbrel in Part B
n=44 Participants
US sourced Enbrel: SC administration
|
EU Sourced Enbrel in Part C
n=42 Participants
EU sourced Enbrel: SC administration
|
US Sourced Enbrel in Part C
n=42 Participants
US sourced Enbrel: SC administration
|
|---|---|---|---|---|---|---|
|
Time to Cmax (Tmax)
|
75.198 h
Standard Deviation 29.1358
|
71.711 h
Standard Deviation 24.7538
|
75.263 h
Standard Deviation 30.8374
|
70.385 h
Standard Deviation 22.4972
|
70.276 h
Standard Deviation 30.3826
|
71.150 h
Standard Deviation 29.7904
|
Adverse Events
SB4 in Part A
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
EU Sourced Enbrel in Part A
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
SB4 in Part B
Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths
US Sourced Enbrel in Part B
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
EU Sourced Enbrel in Part C
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
US Sourced Enbrel in Part C
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
SB4 in Part A
n=46 participants at risk
SB4: SC administration
|
EU Sourced Enbrel in Part A
n=46 participants at risk
EU sourced Enbrel: SC administration
|
SB4 in Part B
n=46 participants at risk
SB4: SC administration
|
US Sourced Enbrel in Part B
n=46 participants at risk
US sourced Enbrel: SC administration
|
EU Sourced Enbrel in Part C
n=46 participants at risk
EU sourced Enbrel: SC administration
|
US Sourced Enbrel in Part C
n=46 participants at risk
US sourced Enbrel: SC administration
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
4.3%
2/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Gastrointestinal disorders
Abdominal distension
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
4.3%
2/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Gastrointestinal disorders
Lip erosion
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
General disorders
Injection site reaction
|
4.3%
2/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
6.5%
3/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
6.5%
3/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
6.5%
3/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
6.5%
3/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
General disorders
Chest discomfort
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Infections and infestations
Nasopharyngitis
|
10.9%
5/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
4.3%
2/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
4.3%
2/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
4.3%
2/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
4.3%
2/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Infections and infestations
Rhinitis
|
4.3%
2/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
4.3%
2/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Infections and infestations
Pharyngitis
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
4.3%
2/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
4.3%
2/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Infections and infestations
Oral herpes
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
6.5%
3/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Nervous system disorders
Headache
|
8.7%
4/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
4.3%
2/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
6.5%
3/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
8.7%
4/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
8.7%
4/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
6.5%
3/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Cardiac disorders
Palpitations
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
4.3%
2/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Gastrointestinal disorders
Aphthous stomatitis
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
General disorders
Asthenia
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
General disorders
Fatigue
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
4.3%
2/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
4.3%
2/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
General disorders
Influenza like illness
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Injury, poisoning and procedural complications
Traumatic haematoma
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Nervous system disorders
Dizziness
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
6.5%
3/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Nervous system disorders
Dizziness postural
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Reproductive system and breast disorders
Erection increased
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
4.3%
2/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Gastrointestinal disorders
Lip blister
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Gastrointestinal disorders
Oral discomfort
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Infections and infestations
Folliculitis
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Nervous system disorders
Somnolence
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
|
Vascular disorders
Hot flush
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
2.2%
1/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
0.00%
0/46 • 7 weeks (49 days) after first dose administration of SB4, EU sourced Enbrel, or US sourced Enbrel
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place