Trial Outcomes & Findings for Establishing a Controlled Human Infection Model of Bordetella Pertussis (NCT NCT05136599)
NCT ID: NCT05136599
Last Updated: 2026-06-22
Results Overview
Mild, Grade 1, symptoms of pertussis are symptoms that do not interfere with everyday activities. They may include malaise, rhinorrhea, sneezing and/or lacrimation, low-grade fever, or cough.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
79 participants
Primary outcome timeframe
Day 0 (challenge day) to Day 16
Results posted on
2026-06-22
Participant Flow
This clinical trial was conducted as two dependent studies. Up to 10 doses were approved to be tested to the maximum of 5 x 10\^7 CFU (Dose #10) for Study 1 and Study 2. A Sub-study was approved to expand on the pertussis symptomatic infection rate. Participants were allocated consecutively to challenge dose groups. As some participants received the same treatment as participants from the other study or sub-study, the results were pooled for analysis.
Participant milestones
| Measure |
Dose #3
Challenge dose of 10\^4 cfu B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #5
Challenge dose of 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #6
Challenge dose of 5 x 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #7
Challenge dose of 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #8
Challenge dose of 5 x 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #9
Challenge dose of 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #10
Challenge dose of 5 x 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #11
Challenge dose of 10\^8 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
7
|
5
|
6
|
6
|
10
|
23
|
12
|
10
|
|
Overall Study
COMPLETED
|
6
|
5
|
5
|
6
|
10
|
22
|
12
|
9
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Dose #3
Challenge dose of 10\^4 cfu B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #5
Challenge dose of 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #6
Challenge dose of 5 x 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #7
Challenge dose of 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #8
Challenge dose of 5 x 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #9
Challenge dose of 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #10
Challenge dose of 5 x 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #11
Challenge dose of 10\^8 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
1
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
concurrent Bordetalla branchiseptica infection
|
0
|
0
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Establishing a Controlled Human Infection Model of Bordetella Pertussis
Baseline characteristics by cohort
| Measure |
Dose #3
n=6 Participants
Challenge dose of 10\^4 cfu B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #5
n=5 Participants
Challenge dose of 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #6
n=5 Participants
Challenge dose of 5 x 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #7
n=6 Participants
Challenge dose of 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #8
n=10 Participants
Challenge dose of 5 x 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #9
n=22 Participants
Challenge dose of 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #10
n=12 Participants
Challenge dose of 5 x 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #11
n=9 Participants
Challenge dose of 10\^8 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
29.5 Years old
STANDARD_DEVIATION 7.06 • n=20 Participants
|
30 Years old
STANDARD_DEVIATION 3.39 • n=20 Participants
|
31.6 Years old
STANDARD_DEVIATION 2.88 • n=40 Participants
|
31.8 Years old
STANDARD_DEVIATION 3.76 • n=6 Participants
|
27.7 Years old
STANDARD_DEVIATION 4.27 • n=7 Participants
|
26.4 Years old
STANDARD_DEVIATION 6.44 • n=13 Participants
|
29 Years old
STANDARD_DEVIATION 6.21 • n=6 Participants
|
27.6 Years old
STANDARD_DEVIATION 5.22 • n=6 Participants
|
28.4 Years old
STANDARD_DEVIATION 5.6 • n=5 Participants
|
|
Sex/Gender, Customized
Male (Sex assigned at birth)
|
3 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=13 Participants
|
5 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
39 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female (Sex assigned at birth)
|
3 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=13 Participants
|
7 Participants
n=6 Participants
|
4 Participants
n=6 Participants
|
36 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender: Boy/Man
|
3 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
4 Participants
n=6 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=13 Participants
|
4 Participants
n=6 Participants
|
5 Participants
n=6 Participants
|
35 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender: Girl/Woman
|
3 Participants
n=20 Participants
|
3 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
2 Participants
n=6 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=13 Participants
|
7 Participants
n=6 Participants
|
3 Participants
n=6 Participants
|
31 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender: Unknown
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Gender: Other
|
0 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=13 Participants
|
1 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
6 Participants
n=6 Participants
|
8 Participants
n=7 Participants
|
20 Participants
n=13 Participants
|
12 Participants
n=6 Participants
|
8 Participants
n=6 Participants
|
70 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=6 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=13 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=6 Participants
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 0 (challenge day) to Day 16Mild, Grade 1, symptoms of pertussis are symptoms that do not interfere with everyday activities. They may include malaise, rhinorrhea, sneezing and/or lacrimation, low-grade fever, or cough.
Outcome measures
| Measure |
Dose #3
n=6 Participants
Challenge dose of 10\^4 cfu B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #5
n=5 Participants
Challenge dose of 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #6
n=5 Participants
Challenge dose of 5 x 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #7
n=6 Participants
Challenge dose of 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #8
n=10 Participants
Challenge dose of 5 x 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #9
n=22 Participants
Challenge dose of 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #10
n=12 Participants
Challenge dose of 5 x 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #11
n=9 Participants
Challenge dose of 10\^8 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Mild Symptoms of Early Pertussis Disease Postchallenge
|
4 participants
|
3 participants
|
5 participants
|
6 participants
|
7 participants
|
21 participants
|
9 participants
|
8 participants
|
SECONDARY outcome
Timeframe: Day 1 to Day 14The presence of B. pertussis is detected by positive culture (i.e., presence of any B. pertussis colonies) of nasopharyngeal samples. It is also detected by a positive PCR (polymerase chain reaction) test of nasopharyngeal samples. Both methods are used in this study; a positive result in either culture and/or PCR test demonstrates shedding of B. pertussis.
Outcome measures
| Measure |
Dose #3
n=6 Participants
Challenge dose of 10\^4 cfu B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #5
n=5 Participants
Challenge dose of 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #6
n=5 Participants
Challenge dose of 5 x 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #7
n=6 Participants
Challenge dose of 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #8
n=10 Participants
Challenge dose of 5 x 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #9
n=22 Participants
Challenge dose of 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #10
n=12 Participants
Challenge dose of 5 x 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #11
n=9 Participants
Challenge dose of 10\^8 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants Who Demonstrate Shedding of Bordetella Pertussis Postchallenge as Determined by Positive Culture and/or PCR Test of Nasopharyngeal Samples
|
0 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
6 Participants
|
19 Participants
|
11 Participants
|
8 Participants
|
Adverse Events
Dose #9
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Dose #10
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
Dose #11
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Dose #3
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Dose #5
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose #6
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose #7
Serious events: 1 serious events
Other events: 4 other events
Deaths: 0 deaths
Dose #8
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Dose #9
n=22 participants at risk
Challenge dose of 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #10
n=12 participants at risk
Challenge dose of 5 x 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #11
n=9 participants at risk
Challenge dose of 10\^8 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #3
n=6 participants at risk
Challenge dose of 10\^4 cfu B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #5
n=5 participants at risk
Challenge dose of 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #6
n=5 participants at risk
Challenge dose of 5 x 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #7
n=6 participants at risk
Challenge dose of 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #8
n=10 participants at risk
Challenge dose of 5 x 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
|---|---|---|---|---|---|---|---|---|
|
Surgical and medical procedures
Bone graft
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • Number of events 1 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
General disorders
Dehiscence
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
Other adverse events
| Measure |
Dose #9
n=22 participants at risk
Challenge dose of 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #10
n=12 participants at risk
Challenge dose of 5 x 10\^7 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #11
n=9 participants at risk
Challenge dose of 10\^8 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #3
n=6 participants at risk
Challenge dose of 10\^4 cfu B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #5
n=5 participants at risk
Challenge dose of 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #6
n=5 participants at risk
Challenge dose of 5 x 10\^5 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #7
n=6 participants at risk
Challenge dose of 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
Dose #8
n=10 participants at risk
Challenge dose of 5 x 10\^6 CFU B. pertussis in 0.2 mL (0.1 mL per naris)
|
|---|---|---|---|---|---|---|---|---|
|
General disorders and administration site conditions
Influenza like illness
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Ear and labyrinth disorders
Ear pain
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
11.1%
1/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Investigations
Enterovirus test positive
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.6%
3/22 • From enrollment until end of follow-up, up to 365 days
|
16.7%
2/12 • From enrollment until end of follow-up, up to 365 days
|
22.2%
2/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
33.3%
2/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
General disorders and administration site conditions
Fatigue
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Gastrointestinal disorders
Flatulence
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Vascular disorders
Flushing
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
8.3%
1/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Nervous system disorders
Headache
|
9.1%
2/22 • From enrollment until end of follow-up, up to 365 days
|
25.0%
3/12 • From enrollment until end of follow-up, up to 365 days
|
22.2%
2/9 • From enrollment until end of follow-up, up to 365 days
|
83.3%
5/6 • From enrollment until end of follow-up, up to 365 days
|
40.0%
2/5 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
33.3%
2/6 • From enrollment until end of follow-up, up to 365 days
|
20.0%
2/10 • From enrollment until end of follow-up, up to 365 days
|
|
Investigations
Human rhinovirus test positive
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Vascular disorders
Hypertension
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
8.3%
1/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Infections and infestations
Influenza
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
10.0%
1/10 • From enrollment until end of follow-up, up to 365 days
|
|
Blood and lymphatic system disorders
Lymph node pain
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
8.3%
1/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Investigations
Lymph node palpable
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
8.3%
1/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
9.1%
2/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
11.1%
1/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
General disorders and administration site conditions
Malaise
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
8.3%
1/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Gastrointestinal disorders
Mouth cyst
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
8.3%
1/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
33.3%
2/6 • From enrollment until end of follow-up, up to 365 days
|
40.0%
2/5 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
40.0%
2/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Gastrointestinal disorders
Nausea
|
9.1%
2/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
11.1%
1/9 • From enrollment until end of follow-up, up to 365 days
|
33.3%
2/6 • From enrollment until end of follow-up, up to 365 days
|
40.0%
2/5 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
8.3%
1/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
General disorders and administration site conditions
Nodule
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
8.3%
1/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
General disorders and administration site conditions
Pain
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
11.1%
1/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
9.1%
2/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Rhinalgia
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
8.3%
1/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Injury, poisoning and procedural complications
Skin laceration
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Nervous system disorders
Syncope
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Cardiac disorders
Tachycardia
|
9.1%
2/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
General disorders and administration site conditions
Tenderness
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
33.3%
2/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar erythema
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
8.3%
1/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Gastrointestinal disorders
Tooth impacted
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Gastrointestinal disorders
Toothache
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Nervous system disorders
Tremor
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Surgical and medical procedures
Venipuncture
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
8.3%
1/12 • From enrollment until end of follow-up, up to 365 days
|
11.1%
1/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
General disorders and administration site conditions
Vessel puncture site pain
|
9.1%
2/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
33.3%
2/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
General disorders and administration site conditions
Vessel puncture site rash
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
8.3%
1/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
General disorders and administration site conditions
Asthenia
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Eye disorders
Asthenopia
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
10.0%
1/10 • From enrollment until end of follow-up, up to 365 days
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Investigations
Blood pressure increased
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Investigations
Bordetella test positive
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
10.0%
1/10 • From enrollment until end of follow-up, up to 365 days
|
|
Infections and infestations
COVID-19
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
General disorders and administration site conditions
Chest discomfort
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
8.3%
1/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
33.3%
2/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
General disorders and administration site conditions
Chills
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
11.1%
1/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
11.1%
1/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
40.0%
2/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Nervous system disorders
Dizziness
|
18.2%
4/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
11.1%
1/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Gastrointestinal disorders
Dyspepsia
|
9.1%
2/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Gastrointestinal disorders
Dysphagia
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Ear and labyrinth disorders
Ear canal erythema
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Gastrointestinal disorders
Abdominal pain
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
8.3%
1/12 • From enrollment until end of follow-up, up to 365 days
|
11.1%
1/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
16.7%
1/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
40.0%
2/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
10.0%
1/10 • From enrollment until end of follow-up, up to 365 days
|
|
Musculoskeletal and connective tissue disorders
Joint stiffness
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
10.0%
1/10 • From enrollment until end of follow-up, up to 365 days
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Injury, poisoning and procedural complications
Limb injury
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
4.5%
1/22 • From enrollment until end of follow-up, up to 365 days
|
8.3%
1/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Nervous system disorders
Presyncope
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
8.3%
1/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
|
General disorders and administration site conditions
Pyrexia
|
0.00%
0/22 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/12 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/9 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
20.0%
1/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/5 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/6 • From enrollment until end of follow-up, up to 365 days
|
0.00%
0/10 • From enrollment until end of follow-up, up to 365 days
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place