Trial Outcomes & Findings for Hulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and Immunogenicity (NCT NCT05637515)
NCT ID: NCT05637515
Last Updated: 2024-10-22
Results Overview
AUCτ, 26-28 (Area under the adalimumab concentration-time curve \[AUC\] over the dosing interval of Week 26-28)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
374 participants
Primary outcome timeframe
Week 26 - 28
Results posted on
2024-10-22
Participant Flow
A total of 374 subjects were randomized into the randomized interchangeable treatment period which comprised of two groups, Group 1 and Group 2. Subjects in Group 1 (N=193), continued to receive Humira (40 mg every other week) until Week 26/Visit 14; While subjects in Group 2 (N=181), underwent multiple switches until Week 26/Visit 14: Hulio (40 mg every other week) for 4 weeks, Humira (40 mg every other week) for 4 weeks, and Hulio (40 mg every other week) for 8 weeks.
Participant milestones
| Measure |
Group 1 :- Humira Continuously
Subjects received Humira continuously during both periods:
Run-in Period: Initial Humira 80 mg dose (two 40 mg doses) on Day 1, followed by 40 mg SC every other week from Week 1 to Week 10.
Randomized Interchangeable Treatment Period: 40 mg SC every other week until Week 26/Visit 14.
|
Group 2:- Repeated Switches Humira - Hulio
Subjects switched between Humira and Hulio:
Run-in Period: Humira 80 mg on Day 1, then 40 mg SC every other week until Week 10.
Randomized Period: Switched treatments until Week 26:
1. Hulio 40 mg every other week for 4 weeks.
2. Humira 40 mg every other week for 4 weeks.
3. Hulio 40 mg every other week for 8 weeks. Randomization was based on Week 12 PASI response.
|
|---|---|---|
|
Overall Study
STARTED
|
193
|
181
|
|
Overall Study
COMPLETED
|
176
|
164
|
|
Overall Study
NOT COMPLETED
|
17
|
17
|
Reasons for withdrawal
| Measure |
Group 1 :- Humira Continuously
Subjects received Humira continuously during both periods:
Run-in Period: Initial Humira 80 mg dose (two 40 mg doses) on Day 1, followed by 40 mg SC every other week from Week 1 to Week 10.
Randomized Interchangeable Treatment Period: 40 mg SC every other week until Week 26/Visit 14.
|
Group 2:- Repeated Switches Humira - Hulio
Subjects switched between Humira and Hulio:
Run-in Period: Humira 80 mg on Day 1, then 40 mg SC every other week until Week 10.
Randomized Period: Switched treatments until Week 26:
1. Hulio 40 mg every other week for 4 weeks.
2. Humira 40 mg every other week for 4 weeks.
3. Hulio 40 mg every other week for 8 weeks. Randomization was based on Week 12 PASI response.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
17
|
17
|
Baseline Characteristics
Hulio Interchangeability to Humira®, Comparing Pharmacokinetics, Efficacy, Safety and Immunogenicity
Baseline characteristics by cohort
| Measure |
Group 1 :- Humira Continuously
n=193 Participants
Subjects received Humira continuously during both periods:
Run-in Period: Initial Humira 80 mg dose (two 40 mg doses) on Day 1, followed by 40 mg SC every other week from Week 1 to Week 10.
Randomized Interchangeable Treatment Period: 40 mg SC every other week until Week 26/Visit 14.
|
Group 2 :- Repeated Switches Humira - Hulio
n=181 Participants
Subjects switched between Humira and Hulio:
Run-in Period: Humira 80 mg on Day 1, then 40 mg SC every other week until Week 10.
Randomized Period: Switched treatments until Week 26:
1. Hulio 40 mg every other week for 4 weeks.
2. Humira 40 mg every other week for 4 weeks.
3. Hulio 40 mg every other week for 8 weeks.
Randomization was based on Week 12 PASI response.
|
Total
n=374 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
173 Participants
n=5 Participants
|
158 Participants
n=7 Participants
|
331 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Age, Continuous
|
46.4 Years
STANDARD_DEVIATION 12.86 • n=5 Participants
|
45.7 Years
STANDARD_DEVIATION 13.40 • n=7 Participants
|
46.0 Years
STANDARD_DEVIATION 13.11 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
132 Participants
n=5 Participants
|
112 Participants
n=7 Participants
|
244 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
192 Participants
n=5 Participants
|
179 Participants
n=7 Participants
|
371 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
191 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
372 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Czechia
|
32 participants
n=5 Participants
|
30 participants
n=7 Participants
|
62 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
112 participants
n=5 Participants
|
100 participants
n=7 Participants
|
212 participants
n=5 Participants
|
|
Region of Enrollment
Bulgaria
|
45 participants
n=5 Participants
|
46 participants
n=7 Participants
|
91 participants
n=5 Participants
|
|
Region of Enrollment
Estonia
|
4 participants
n=5 Participants
|
5 participants
n=7 Participants
|
9 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 26 - 28AUCτ, 26-28 (Area under the adalimumab concentration-time curve \[AUC\] over the dosing interval of Week 26-28)
Outcome measures
| Measure |
Group 1 :- Humira Continuously
n=166 Participants
Subjects received Humira continuously during both periods:
Run-in Period: Initial Humira 80 mg dose (two 40 mg doses) on Day 1, followed by 40 mg SC every other week from Week 1 to Week 10.
Randomized Interchangeable Treatment Period: 40 mg SC every other week until Week 26/Visit 14.
|
Group 2:- Repeated Switches Humira - Hulio
n=159 Participants
Subjects switched between Humira and Hulio:
Run-in Period: Humira 80 mg on Day 1, then 40 mg SC every other week until Week 10.
Randomized Period: Switched treatments until Week 26:
1. Hulio 40 mg every other week for 4 weeks.
2. Humira 40 mg every other week for 4 weeks.
3. Hulio 40 mg every other week for 8 weeks.
Randomization was based on Week 12 PASI response.
|
|---|---|---|
|
Primary Endpoints: Pharmacokinetics (PK) - AUC
|
2127.57 h*ug/mL
Standard Deviation 1432.80
|
2357.61 h*ug/mL
Standard Deviation 1636.09
|
PRIMARY outcome
Timeframe: Week 26 - 28Cmax, 26-28 (Maximum observed adalimumab concentration during the dosing interval Week 26-28).
Outcome measures
| Measure |
Group 1 :- Humira Continuously
n=166 Participants
Subjects received Humira continuously during both periods:
Run-in Period: Initial Humira 80 mg dose (two 40 mg doses) on Day 1, followed by 40 mg SC every other week from Week 1 to Week 10.
Randomized Interchangeable Treatment Period: 40 mg SC every other week until Week 26/Visit 14.
|
Group 2:- Repeated Switches Humira - Hulio
n=159 Participants
Subjects switched between Humira and Hulio:
Run-in Period: Humira 80 mg on Day 1, then 40 mg SC every other week until Week 10.
Randomized Period: Switched treatments until Week 26:
1. Hulio 40 mg every other week for 4 weeks.
2. Humira 40 mg every other week for 4 weeks.
3. Hulio 40 mg every other week for 8 weeks.
Randomization was based on Week 12 PASI response.
|
|---|---|---|
|
Primary Endpoints: Pharmacokinetics (PK) - Cmax
|
7.69 ug/mL
Standard Deviation 4.96
|
8.46 ug/mL
Standard Deviation 5.42
|
Adverse Events
Group 1:- Humira Continuously
Serious events: 3 serious events
Other events: 66 other events
Deaths: 0 deaths
Group 2:- Repeated Switches Humira - Hulio
Serious events: 3 serious events
Other events: 54 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Group 1:- Humira Continuously
n=193 participants at risk
Subjects received Humira continuously during both periods:
Run-in Period: Initial Humira 80 mg dose (two 40 mg doses) on Day 1, followed by 40 mg SC every other week from Week 1 to Week 10.
Randomized Interchangeable Treatment Period: 40 mg SC every other week until Week 26/Visit 14.
|
Group 2:- Repeated Switches Humira - Hulio
n=181 participants at risk
Subjects switched between Humira and Hulio:
Run-in Period: Humira 80 mg on Day 1, then 40 mg SC every other week until Week 10.
Randomized Period: Switched treatments until Week 26:
1. Hulio 40 mg every other week for 4 weeks.
2. Humira 40 mg every other week for 4 weeks.
2\. Hulio 40 mg every other week for 8 weeks. Randomization was based on Week 12 PASI response.
|
|---|---|---|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/193 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.55%
1/181 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Vestibular neuronitis
|
0.52%
1/193 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.00%
0/181 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Cardiac disorders
Acute myocardial infarction
|
0.52%
1/193 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.00%
0/181 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.52%
1/193 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.00%
0/181 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.00%
0/193 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.55%
1/181 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/193 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.55%
1/181 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Vascular disorders
Deep vein thrombosis
|
0.52%
1/193 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.00%
0/181 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
Other adverse events
| Measure |
Group 1:- Humira Continuously
n=193 participants at risk
Subjects received Humira continuously during both periods:
Run-in Period: Initial Humira 80 mg dose (two 40 mg doses) on Day 1, followed by 40 mg SC every other week from Week 1 to Week 10.
Randomized Interchangeable Treatment Period: 40 mg SC every other week until Week 26/Visit 14.
|
Group 2:- Repeated Switches Humira - Hulio
n=181 participants at risk
Subjects switched between Humira and Hulio:
Run-in Period: Humira 80 mg on Day 1, then 40 mg SC every other week until Week 10.
Randomized Period: Switched treatments until Week 26:
1. Hulio 40 mg every other week for 4 weeks.
2. Humira 40 mg every other week for 4 weeks.
2\. Hulio 40 mg every other week for 8 weeks. Randomization was based on Week 12 PASI response.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
5.7%
11/193 • Number of events 11 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
2.2%
4/181 • Number of events 4 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
4/193 • Number of events 4 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
2.2%
4/181 • Number of events 4 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Pharyngitis
|
2.1%
4/193 • Number of events 4 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
1.1%
2/181 • Number of events 2 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Rhinitis
|
1.6%
3/193 • Number of events 3 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.55%
1/181 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Tonsillitis
|
1.0%
2/193 • Number of events 2 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
1.1%
2/181 • Number of events 2 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Urinary tract infection
|
1.0%
2/193 • Number of events 2 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
1.1%
2/181 • Number of events 2 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Influenza
|
0.52%
1/193 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
1.1%
2/181 • Number of events 2 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Sinusitis
|
1.0%
2/193 • Number of events 2 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.55%
1/181 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
General disorders
Injection site erythema
|
1.6%
3/193 • Number of events 10 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
1.7%
3/181 • Number of events 4 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
General disorders
Injection site pain
|
2.1%
4/193 • Number of events 6 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.55%
1/181 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
General disorders
Injection site pruritus
|
1.0%
2/193 • Number of events 6 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
1.1%
2/181 • Number of events 4 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
General disorders
Injection site swelling
|
1.0%
2/193 • Number of events 7 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
1.1%
2/181 • Number of events 2 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.0%
2/193 • Number of events 2 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
1.7%
3/181 • Number of events 5 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.52%
1/193 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
1.1%
2/181 • Number of events 2 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Musculoskeletal and connective tissue disorders
Psoriatic arthropathy
|
0.00%
0/193 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
1.7%
3/181 • Number of events 3 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Nervous system disorders
Headache
|
3.1%
6/193 • Number of events 8 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
2.2%
4/181 • Number of events 6 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
1.6%
3/193 • Number of events 3 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
1.1%
2/181 • Number of events 2 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Investigations
Alanine aminotransferase increased
|
2.6%
5/193 • Number of events 5 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
1.7%
3/181 • Number of events 4 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Investigations
Gamma-glutamyltransferase increased
|
1.6%
3/193 • Number of events 3 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
1.7%
3/181 • Number of events 4 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Investigations
Aspartate aminotransferase increased
|
1.6%
3/193 • Number of events 4 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
1.1%
2/181 • Number of events 2 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Gastrointestinal disorders
Diarrhoea
|
1.0%
2/193 • Number of events 2 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
1.1%
2/181 • Number of events 2 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Vascular disorders
Hypertension
|
2.1%
4/193 • Number of events 4 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.55%
1/181 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Oral herpes
|
1.0%
2/193 • Number of events 2 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.00%
0/181 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Pulpitis dental
|
1.0%
2/193 • Number of events 2 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.00%
0/181 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/193 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.55%
1/181 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Bronchitis
|
0.52%
1/193 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.00%
0/181 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
COVID-19
|
0.00%
0/193 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.55%
1/181 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
COVID-19 pneumonia
|
0.00%
0/193 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.55%
1/181 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Folliculitis
|
0.00%
0/193 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.55%
1/181 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/193 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.55%
1/181 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/193 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.55%
1/181 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/193 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.55%
1/181 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Helicobacter infection
|
0.52%
1/193 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.00%
0/181 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Lyme disease
|
0.52%
1/193 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.00%
0/181 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Oral candidiasis
|
0.52%
1/193 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.00%
0/181 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/193 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.55%
1/181 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Pseudomonas infection
|
0.00%
0/193 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.55%
1/181 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Skin candida
|
0.52%
1/193 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.00%
0/181 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Varicella zoster virus infection
|
0.52%
1/193 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.00%
0/181 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Vestibular neuronitis
|
0.52%
1/193 • Number of events 3 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.00%
0/181 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.52%
1/193 • Number of events 1 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
0.00%
0/181 • 16 weeks
One subject in Group 2, died due to COVID-19 pneumonia. The details of adverse events leading to death
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Institution and Investigator shall have the right to publish or present the results of Institution. Institution and Investigator are required to submit any proposed publication or presentation to Sponsor for review at least 30 days prior to submitting any such proposed publication. Sponsor shall advise Institution and/or Investigator, as the case may be, in writing of any information contained therein which is Confidential Information (other than Study Data).
- Publication restrictions are in place
Restriction type: OTHER