Trial Outcomes & Findings for Phase I Study to Assess the Safety and Immunology of a COVID-19 Vaccine With GRAd-COV2 Vaccine (NCT NCT04528641)
NCT ID: NCT04528641
Last Updated: 2022-02-08
Results Overview
Participants were monitored for 7 days post-vaccination and the occurrence of solicited local AE signs and symptoms were collected.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
98 participants
Primary outcome timeframe
7 days following the vaccination
Results posted on
2022-02-08
Participant Flow
a total of 180 subjects were screened and 98 subjects were enrolled in the study. seven out of 98 enrolled subjects were not administered vaccine because of withdrawal by subjects (3 subjects) and because the protocol allowed Screening period 21 days passed (4 subjects). a total of 91 subjects were administered vaccine.
Participant milestones
| Measure |
Arm 1 - Low Dose
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
15
|
16
|
15
|
15
|
|
Overall Study
COMPLETED
|
15
|
15
|
15
|
15
|
15
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
1
|
0
|
1
|
Reasons for withdrawal
| Measure |
Arm 1 - Low Dose
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
0
|
1
|
Baseline Characteristics
Phase I Study to Assess the Safety and Immunology of a COVID-19 Vaccine With GRAd-COV2 Vaccine
Baseline characteristics by cohort
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Total
n=91 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
45 Participants
n=8 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
15 Participants
n=8 Participants
|
46 Participants
n=8 Participants
|
|
Age, Continuous
|
33.9 years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
37.0 years
STANDARD_DEVIATION 10.2 • n=7 Participants
|
36.2 years
STANDARD_DEVIATION 11.1 • n=5 Participants
|
69.5 years
STANDARD_DEVIATION 4.6 • n=4 Participants
|
70.8 years
STANDARD_DEVIATION 5.6 • n=21 Participants
|
70.0 years
STANDARD_DEVIATION 3.5 • n=8 Participants
|
53.1 years
STANDARD_DEVIATION 18.9 • n=8 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
33 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
10 Participants
n=8 Participants
|
58 Participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
1 participants
n=8 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
15 participants
n=5 Participants
|
14 participants
n=7 Participants
|
15 participants
n=5 Participants
|
16 participants
n=4 Participants
|
15 participants
n=21 Participants
|
15 participants
n=8 Participants
|
90 participants
n=8 Participants
|
|
Region of Enrollment
Italy
|
15 participants
n=5 Participants
|
15 participants
n=7 Participants
|
15 participants
n=5 Participants
|
16 participants
n=4 Participants
|
15 participants
n=21 Participants
|
15 participants
n=8 Participants
|
91 participants
n=8 Participants
|
|
Demographic - weight
|
73.9 kg
STANDARD_DEVIATION 12.172 • n=5 Participants
|
69.7 kg
STANDARD_DEVIATION 14.91 • n=7 Participants
|
70.9 kg
STANDARD_DEVIATION 13.49 • n=5 Participants
|
73.61 kg
STANDARD_DEVIATION 12.874 • n=4 Participants
|
70.37 kg
STANDARD_DEVIATION 10.181 • n=21 Participants
|
70.9 kg
STANDARD_DEVIATION 10.54 • n=8 Participants
|
71.59 kg
STANDARD_DEVIATION 12.224 • n=8 Participants
|
|
Demographic - Height
|
173.3 cm
STANDARD_DEVIATION 9.82 • n=5 Participants
|
171.9 cm
STANDARD_DEVIATION 10.93 • n=7 Participants
|
173.8 cm
STANDARD_DEVIATION 10.21 • n=5 Participants
|
169.0 cm
STANDARD_DEVIATION 9.01 • n=4 Participants
|
168.1 cm
STANDARD_DEVIATION 11.30 • n=21 Participants
|
169.7 cm
STANDARD_DEVIATION 9.47 • n=8 Participants
|
170.9 cm
STANDARD_DEVIATION 10.12 • n=8 Participants
|
|
Demographic - BMI
|
24.514 Kg/m^2
STANDARD_DEVIATION 2.5747 • n=5 Participants
|
23.367 Kg/m^2
STANDARD_DEVIATION 3.0412 • n=7 Participants
|
23.332 Kg/m^2
STANDARD_DEVIATION 2.7751 • n=5 Participants
|
24.767 Kg/m^2
STANDARD_DEVIATION 3.0552 • n=4 Participants
|
24.574 Kg/m^2
STANDARD_DEVIATION 2.5569 • n=21 Participants
|
25.035 Kg/m^2
STANDARD_DEVIATION 2.2006 • n=8 Participants
|
24.514 Kg/m^2
STANDARD_DEVIATION 2.5747 • n=8 Participants
|
PRIMARY outcome
Timeframe: 7 days following the vaccinationParticipants were monitored for 7 days post-vaccination and the occurrence of solicited local AE signs and symptoms were collected.
Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Occurrence of Solicited Local AE Signs and Symptoms 7 Days Following the Vaccination
Injection site pain
|
10 Participants
|
12 Participants
|
10 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
|
Occurrence of Solicited Local AE Signs and Symptoms 7 Days Following the Vaccination
Injection site erythema
|
1 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence of Solicited Local AE Signs and Symptoms 7 Days Following the Vaccination
Injection site swelling
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence of Solicited Local AE Signs and Symptoms 7 Days Following the Vaccination
Injection site Haematoma
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 7 days following the vaccinationParticipants were monitored for 7 days post-vaccination and the occurrence of solicited systemic AE signs and symptoms were collected.
Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Fatigue
|
8 Participants
|
7 Participants
|
10 Participants
|
7 Participants
|
2 Participants
|
4 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Pyrexia
|
3 Participants
|
4 Participants
|
11 Participants
|
4 Participants
|
4 Participants
|
4 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Cough
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Hot flush
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Tooth abscess
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Chalazion
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Headache
|
5 Participants
|
6 Participants
|
10 Participants
|
6 Participants
|
3 Participants
|
2 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Myalgia
|
1 Participants
|
5 Participants
|
4 Participants
|
5 Participants
|
1 Participants
|
5 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Chills
|
1 Participants
|
1 Participants
|
6 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Nausea
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Neutropeonia
|
1 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Abdominal Pain
|
1 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Diarrhoea
|
1 Participants
|
3 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Arthralgia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Back Pain
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Faeces Soft
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Hyperkalaemia
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Muscle injury
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Muscle strain
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Tooth fracture
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Dyspnoea
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Oropharyngeal pain
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Ecchymosis
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Solicited Systemic AE Signs and Symptoms 7 Days Following the Vaccination
Lymphadenopathy
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 28 days following the vaccinationOccurrence of unsolicited AEs: unsolicited AEs were collected using the patient Diary and reported as "Any AE" occurring 28 days following the vaccination.
Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Occurrence of Unsolicited AE 28 Days Following the Vaccination
week 1 - any AE : Mild
|
9 Participants
|
9 Participants
|
13 Participants
|
9 Participants
|
6 Participants
|
7 Participants
|
|
Occurrence of Unsolicited AE 28 Days Following the Vaccination
week 1 - any AE : Moderate
|
3 Participants
|
5 Participants
|
6 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Occurrence of Unsolicited AE 28 Days Following the Vaccination
week 1 - any AE : Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence of Unsolicited AE 28 Days Following the Vaccination
week 2 - any AE: mild
|
5 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Unsolicited AE 28 Days Following the Vaccination
week 2 - any AE: moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Unsolicited AE 28 Days Following the Vaccination
week 2 - any AE: severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Unsolicited AE 28 Days Following the Vaccination
week 3 - Any AE: mild
|
4 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Unsolicited AE 28 Days Following the Vaccination
week 3 - any AE: moderate
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Unsolicited AE 28 Days Following the Vaccination
week 3 - any AE: severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Unsolicited AE 28 Days Following the Vaccination
week 4 - any AE: mild
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Occurrence of Unsolicited AE 28 Days Following the Vaccination
week 4 - any AE: moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Unsolicited AE 28 Days Following the Vaccination
week 4 - any AE: severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 24 weeks following the vaccinationOccurrence of any treatment - emergent serious AE and treatment - emergent SAE related to study drug was monitored during the study period (24 weeks following vaccination)
Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Occurrence of Serious AE 24 Weeks Following the Vaccination
Any treatment-emergent SAE related to study drug
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Serious AE 24 Weeks Following the Vaccination
Any treatment-emergent SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: baseline, Weeks 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Leucocytes From Baseline
week 24
|
-0.695 10^9 leucocytes /L
Standard Deviation 1.199
|
-0.125 10^9 leucocytes /L
Standard Deviation 1.0887
|
-0.263 10^9 leucocytes /L
Standard Deviation 0.8854
|
-0.310 10^9 leucocytes /L
Standard Deviation 1.0615
|
0.196 10^9 leucocytes /L
Standard Deviation 0.7996
|
0.199 10^9 leucocytes /L
Standard Deviation 0.8817
|
|
Change in Leucocytes From Baseline
week 1
|
-0.033 10^9 leucocytes /L
Standard Deviation 1.285
|
-0.199 10^9 leucocytes /L
Standard Deviation 1.3799
|
-0.265 10^9 leucocytes /L
Standard Deviation 0.5758
|
-0.159 10^9 leucocytes /L
Standard Deviation 0.7563
|
-0.019 10^9 leucocytes /L
Standard Deviation 0.4475
|
0.055 10^9 leucocytes /L
Standard Deviation 0.6884
|
|
Change in Leucocytes From Baseline
week 2
|
0.218 10^9 leucocytes /L
Standard Deviation 1.354
|
0.091 10^9 leucocytes /L
Standard Deviation 1.2248
|
-0.099 10^9 leucocytes /L
Standard Deviation 0.6808
|
0.158 10^9 leucocytes /L
Standard Deviation 0.9098
|
0.329 10^9 leucocytes /L
Standard Deviation 0.7771
|
0.190 10^9 leucocytes /L
Standard Deviation 0.6531
|
|
Change in Leucocytes From Baseline
week 4
|
-0.230 10^9 leucocytes /L
Standard Deviation 1.2881
|
0.472 10^9 leucocytes /L
Standard Deviation 1.2324
|
-0.286 10^9 leucocytes /L
Standard Deviation 0.6787
|
-0.261 10^9 leucocytes /L
Standard Deviation 1.0477
|
0.186 10^9 leucocytes /L
Standard Deviation 1.0368
|
0.186 10^9 leucocytes /L
Standard Deviation 1.1456
|
|
Change in Leucocytes From Baseline
week 8
|
0.154 10^9 leucocytes /L
Standard Deviation 0.8825
|
0.094 10^9 leucocytes /L
Standard Deviation 1.2006
|
-0.029 10^9 leucocytes /L
Standard Deviation 1.0882
|
-0.013 10^9 leucocytes /L
Standard Deviation 0.8416
|
0.080 10^9 leucocytes /L
Standard Deviation 0.5862
|
-0.087 10^9 leucocytes /L
Standard Deviation 0.6728
|
|
Change in Leucocytes From Baseline
week 12
|
-0.045 10^9 leucocytes /L
Standard Deviation 1.0228
|
0.409 10^9 leucocytes /L
Standard Deviation 1.7620
|
0.133 10^9 leucocytes /L
Standard Deviation 1.1654
|
-0.060 10^9 leucocytes /L
Standard Deviation 0.9897
|
0.357 10^9 leucocytes /L
Standard Deviation 0.8966
|
-0.175 10^9 leucocytes /L
Standard Deviation 0.7302
|
PRIMARY outcome
Timeframe: Weeks 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Basophils From Baseline
week 1
|
-0.002 10^9 basophils/L
Standard Deviation 0.0094
|
-0.002 10^9 basophils/L
Standard Deviation 0.0147
|
-0.010 10^9 basophils/L
Standard Deviation 0.0169
|
-0.001 10^9 basophils/L
Standard Deviation 0.0141
|
-0.009 10^9 basophils/L
Standard Deviation 0.0113
|
-0.001 10^9 basophils/L
Standard Deviation 0.0162
|
|
Change in Basophils From Baseline
week 2
|
0.001 10^9 basophils/L
Standard Deviation 0.0122
|
0.007 10^9 basophils/L
Standard Deviation 0.0129
|
-0.002 10^9 basophils/L
Standard Deviation 0.0142
|
0.004 10^9 basophils/L
Standard Deviation 0.011
|
0.003 10^9 basophils/L
Standard Deviation 0.0272
|
0.004 10^9 basophils/L
Standard Deviation 0.0124
|
|
Change in Basophils From Baseline
week 4
|
-0.004 10^9 basophils/L
Standard Deviation 0.0118
|
0.0 10^9 basophils/L
Standard Deviation 0.0120
|
-0.003 10^9 basophils/L
Standard Deviation 0.150
|
0.001 10^9 basophils/L
Standard Deviation 0.054
|
-0.003 10^9 basophils/L
Standard Deviation 0.0129
|
0.004 10^9 basophils/L
Standard Deviation 0.0199
|
|
Change in Basophils From Baseline
week 8
|
-0.001 10^9 basophils/L
Standard Deviation 0.0122
|
0.001 10^9 basophils/L
Standard Deviation 0.0133
|
-0.001 10^9 basophils/L
Standard Deviation 0.0119
|
-0.002 10^9 basophils/L
Standard Deviation 0.0164
|
-0.005 10^9 basophils/L
Standard Deviation 0.0092
|
0.003 10^9 basophils/L
Standard Deviation 0.0116
|
|
Change in Basophils From Baseline
week 12
|
0.002 10^9 basophils/L
Standard Deviation 0.0142
|
0.003 10^9 basophils/L
Standard Deviation 0.0159
|
0.0 10^9 basophils/L
Standard Deviation 0.0108
|
0.0 10^9 basophils/L
Standard Deviation 0.0121
|
0.0 10^9 basophils/L
Standard Deviation 0.0156
|
0.002 10^9 basophils/L
Standard Deviation 0.0142
|
|
Change in Basophils From Baseline
week 24
|
-0.004 10^9 basophils/L
Standard Deviation 0.0135
|
0.004 10^9 basophils/L
Standard Deviation 0.0112
|
-0.001 10^9 basophils/L
Standard Deviation 0.0146
|
-0.003 10^9 basophils/L
Standard Deviation 0.0168
|
-0.004 10^9 basophils/L
Standard Deviation 0.0140
|
-0.001 10^9 basophils/L
Standard Deviation 0.0141
|
PRIMARY outcome
Timeframe: Weeks 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Eosinophils From Baseline
week 8
|
-0.023 10^9 eosinophils /L
Standard Deviation 0.0716
|
-0.002 10^9 eosinophils /L
Standard Deviation 0.1202
|
-0.033 10^9 eosinophils /L
Standard Deviation 0.0979
|
0.010 10^9 eosinophils /L
Standard Deviation 0.0732
|
0.006 10^9 eosinophils /L
Standard Deviation 0.0617
|
0.021 10^9 eosinophils /L
Standard Deviation 0.0935
|
|
Change in Eosinophils From Baseline
week 1
|
0.009 10^9 eosinophils /L
Standard Deviation 0.0478
|
-0.017 10^9 eosinophils /L
Standard Deviation 0.0649
|
-0.007 10^9 eosinophils /L
Standard Deviation 0.0555
|
0.031 10^9 eosinophils /L
Standard Deviation 0.0483
|
0.009 10^9 eosinophils /L
Standard Deviation 0.0674
|
0.006 10^9 eosinophils /L
Standard Deviation 0.0467
|
|
Change in Eosinophils From Baseline
week 2
|
0.014 10^9 eosinophils /L
Standard Deviation 0.0370
|
0.029 10^9 eosinophils /L
Standard Deviation 0.0644
|
0.024 10^9 eosinophils /L
Standard Deviation 0.0697
|
0.046 10^9 eosinophils /L
Standard Deviation 0.0574
|
0.037 10^9 eosinophils /L
Standard Deviation 0.0743
|
0.021 10^9 eosinophils /L
Standard Deviation 0.0439
|
|
Change in Eosinophils From Baseline
week 4
|
-0.013 10^9 eosinophils /L
Standard Deviation 0.0873
|
-0.003 10^9 eosinophils /L
Standard Deviation 0.0603
|
-0.003 10^9 eosinophils /L
Standard Deviation 0.0471
|
-0.008 10^9 eosinophils /L
Standard Deviation 0.0680
|
0.001 10^9 eosinophils /L
Standard Deviation 0.0442
|
0.027 10^9 eosinophils /L
Standard Deviation 0.0870
|
|
Change in Eosinophils From Baseline
week 12
|
-0.004 10^9 eosinophils /L
Standard Deviation 0.0840
|
-0.017 10^9 eosinophils /L
Standard Deviation 0.077
|
-0.013 10^9 eosinophils /L
Standard Deviation 0.1085
|
-0.001 10^9 eosinophils /L
Standard Deviation 0.0804
|
0.007 10^9 eosinophils /L
Standard Deviation 0.0707
|
0.02 10^9 eosinophils /L
Standard Deviation 0.0728
|
|
Change in Eosinophils From Baseline
week 24
|
-0.051 10^9 eosinophils /L
Standard Deviation 0.0907
|
-0.013 10^9 eosinophils /L
Standard Deviation 0.0807
|
0.008 10^9 eosinophils /L
Standard Deviation 0.1239
|
0.012 10^9 eosinophils /L
Standard Deviation 0.0914
|
0.015 10^9 eosinophils /L
Standard Deviation 0.0635
|
0.018 10^9 eosinophils /L
Standard Deviation 0.0477
|
PRIMARY outcome
Timeframe: Weeks 1,2,4,8,12, and 24Change from baseline was calculated as the value at each week minus the value at the baseline.
Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Neutrophils From Baseline
week 4
|
-0.273 10^9 Neutrophils /L
Standard Deviation 1.3001
|
-0.417 10^9 Neutrophils /L
Standard Deviation 1.0814
|
-0.273 10^9 Neutrophils /L
Standard Deviation 0.4670
|
-0.208 10^9 Neutrophils /L
Standard Deviation 1.0731
|
0.116 10^9 Neutrophils /L
Standard Deviation 0.8245
|
0.011 10^9 Neutrophils /L
Standard Deviation 1.0820
|
|
Change in Neutrophils From Baseline
week 8
|
-0.131 10^9 Neutrophils /L
Standard Deviation 0.8082
|
0.008 10^9 Neutrophils /L
Standard Deviation 1.1261
|
0.097 10^9 Neutrophils /L
Standard Deviation 0.9320
|
0.054 10^9 Neutrophils /L
Standard Deviation 0.7545
|
-0.025 10^9 Neutrophils /L
Standard Deviation 0.4139
|
-0.148 10^9 Neutrophils /L
Standard Deviation 0.5358
|
|
Change in Neutrophils From Baseline
week 1
|
-0.241 10^9 Neutrophils /L
Standard Deviation 1.1183
|
-0.105 10^9 Neutrophils /L
Standard Deviation 1.3346
|
-0.296 10^9 Neutrophils /L
Standard Deviation 0.5781
|
-0.391 10^9 Neutrophils /L
Standard Deviation 0.7397
|
-0.147 10^9 Neutrophils /L
Standard Deviation 0.3939
|
-0.092 10^9 Neutrophils /L
Standard Deviation 0.5560
|
|
Change in Neutrophils From Baseline
week 2
|
-0.115 10^9 Neutrophils /L
Standard Deviation 1.1387
|
-0.254 10^9 Neutrophils /L
Standard Deviation 1.0089
|
-0.313 10^9 Neutrophils /L
Standard Deviation 0.4109
|
-0.014 10^9 Neutrophils /L
Standard Deviation 0.8032
|
-0.015 10^9 Neutrophils /L
Standard Deviation 0.5966
|
-0.044 10^9 Neutrophils /L
Standard Deviation 0.4523
|
|
Change in Neutrophils From Baseline
week 12
|
-0.159 10^9 Neutrophils /L
Standard Deviation 0.8592
|
0.458 10^9 Neutrophils /L
Standard Deviation 1.8931
|
0.153 10^9 Neutrophils /L
Standard Deviation 1.0128
|
0.027 10^9 Neutrophils /L
Standard Deviation 0.9118
|
0.165 10^9 Neutrophils /L
Standard Deviation 0.6483
|
-0.180 10^9 Neutrophils /L
Standard Deviation 0.6024
|
|
Change in Neutrophils From Baseline
week 24
|
-0.376 10^9 Neutrophils /L
Standard Deviation 1.1492
|
-0.141 10^9 Neutrophils /L
Standard Deviation 0.8632
|
-0.151 10^9 Neutrophils /L
Standard Deviation 0.6475
|
-0.378 10^9 Neutrophils /L
Standard Deviation 0.9802
|
0.073 10^9 Neutrophils /L
Standard Deviation 0.6629
|
0.147 10^9 Neutrophils /L
Standard Deviation 0.7146
|
PRIMARY outcome
Timeframe: Weeks 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Monocytes From Baseline
week 1
|
-0.0040 10^9 Monocytes /L
Standard Deviation 0.0733
|
-0.0227 10^9 Monocytes /L
Standard Deviation 0.11218
|
-0.0353 10^9 Monocytes /L
Standard Deviation 0.0689
|
-0.0525 10^9 Monocytes /L
Standard Deviation 0.0668
|
0.0100 10^9 Monocytes /L
Standard Deviation 0.0860
|
-0.0307 10^9 Monocytes /L
Standard Deviation 0.0694
|
|
Change in Monocytes From Baseline
week 2
|
0.0733 10^9 Monocytes /L
Standard Deviation 0.1011
|
0.0427 10^9 Monocytes /L
Standard Deviation 0.1353
|
0.0227 10^9 Monocytes /L
Standard Deviation 0.1109
|
0.0144 10^9 Monocytes /L
Standard Deviation 0.0999
|
0.0520 10^9 Monocytes /L
Standard Deviation 0.0844
|
0.0280 10^9 Monocytes /L
Standard Deviation 0.0820
|
|
Change in Monocytes From Baseline
week 4
|
-0.0220 10^9 Monocytes /L
Standard Deviation 0.0668
|
-0.0327 10^9 Monocytes /L
Standard Deviation 0.1142
|
-0.0287 10^9 Monocytes /L
Standard Deviation 0.0666
|
-0.0556 10^9 Monocytes /L
Standard Deviation 0.0909
|
0.0400 10^9 Monocytes /L
Standard Deviation 0.1110
|
-0.0193 10^9 Monocytes /L
Standard Deviation 0.0656
|
|
Change in Monocytes From Baseline
week 8
|
0.0073 10^9 Monocytes /L
Standard Deviation 0.0612
|
0.0113 10^9 Monocytes /L
Standard Deviation 0.1336
|
-0.0380 10^9 Monocytes /L
Standard Deviation 0.0927
|
-0.0431 10^9 Monocytes /L
Standard Deviation 0.0624
|
0.0253 10^9 Monocytes /L
Standard Deviation 0.0801
|
-0.0227 10^9 Monocytes /L
Standard Deviation 0.0849
|
|
Change in Monocytes From Baseline
week 12
|
-0.0004 10^9 Monocytes /L
Standard Deviation 0.0797
|
0.0007 10^9 Monocytes /L
Standard Deviation 0.1331
|
-0.0240 10^9 Monocytes /L
Standard Deviation 0.0662
|
-0.0475 10^9 Monocytes /L
Standard Deviation 0.0772
|
0.0453 10^9 Monocytes /L
Standard Deviation 0.0856
|
-0.0387 10^9 Monocytes /L
Standard Deviation 0.0605
|
|
Change in Monocytes From Baseline
week 24
|
-0.0427 10^9 Monocytes /L
Standard Deviation 0.0707
|
-0.0107 10^9 Monocytes /L
Standard Deviation 0.1163
|
-0.0233 10^9 Monocytes /L
Standard Deviation 0.1271
|
-0.0227 10^9 Monocytes /L
Standard Deviation 0.0960
|
0.0493 10^9 Monocytes /L
Standard Deviation 0.1127
|
-0.0021 10^9 Monocytes /L
Standard Deviation 0.0567
|
PRIMARY outcome
Timeframe: Weeks 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Lymphocytes From Baseline
week 1
|
0.209 10^9 Lymphocytes /L
Standard Deviation 0.5808
|
-0.060 10^9 Lymphocytes /L
Standard Deviation 0.4455
|
0.077 10^9 Lymphocytes /L
Standard Deviation 0.2050
|
0.179 10^9 Lymphocytes /L
Standard Deviation 0.2565
|
0.115 10^9 Lymphocytes /L
Standard Deviation 0.2064
|
0.179 10^9 Lymphocytes /L
Standard Deviation 0.2516
|
|
Change in Lymphocytes From Baseline
week 2
|
0.247 10^9 Lymphocytes /L
Standard Deviation 0.3868
|
0.257 10^9 Lymphocytes /L
Standard Deviation 0.3913
|
0.169 10^9 Lymphocytes /L
Standard Deviation 0.4038
|
0.109 10^9 Lymphocytes /L
Standard Deviation 0.2490
|
0.249 10^9 Lymphocytes /L
Standard Deviation 0.2813
|
0.184 10^9 Lymphocytes /L
Standard Deviation 0.3094
|
|
Change in Lymphocytes From Baseline
week 4
|
0.077 10^9 Lymphocytes /L
Standard Deviation 0.4069
|
-0.023 10^9 Lymphocytes /L
Standard Deviation 0.3568
|
0.013 10^9 Lymphocytes /L
Standard Deviation 0.2528
|
0.010 10^9 Lymphocytes /L
Standard Deviation 0.3045
|
0.03 10^9 Lymphocytes /L
Standard Deviation 0.2146
|
0.103 10^9 Lymphocytes /L
Standard Deviation 0.1823
|
|
Change in Lymphocytes From Baseline
week 8
|
-0.012 10^9 Lymphocytes /L
Standard Deviation 0.3490
|
0.063 10^9 Lymphocytes /L
Standard Deviation 0.3991
|
-0.058 10^9 Lymphocytes /L
Standard Deviation 0.2627
|
-0.039 10^9 Lymphocytes /L
Standard Deviation 0.2856
|
0.077 10^9 Lymphocytes /L
Standard Deviation 0.2252
|
0.062 10^9 Lymphocytes /L
Standard Deviation 0.2502
|
|
Change in Lymphocytes From Baseline
week 12
|
0.115 10^9 Lymphocytes /L
Standard Deviation 0.4083
|
-0.045 10^9 Lymphocytes /L
Standard Deviation 0.3655
|
0.015 10^9 Lymphocytes /L
Standard Deviation 0.2884
|
-0.046 10^9 Lymphocytes /L
Standard Deviation 0.3200
|
0.135 10^9 Lymphocytes /L
Standard Deviation 0.2941
|
0.031 10^9 Lymphocytes /L
Standard Deviation 0.2214
|
|
Change in Lymphocytes From Baseline
week 24
|
-0.219 10^9 Lymphocytes /L
Standard Deviation 0.3293
|
0.027 10^9 Lymphocytes /L
Standard Deviation 0.5038
|
-0.097 10^9 Lymphocytes /L
Standard Deviation 0.2514
|
0.072 10^9 Lymphocytes /L
Standard Deviation 0.2427
|
0.064 10^9 Lymphocytes /L
Standard Deviation 0.2607
|
0.049 10^9 Lymphocytes /L
Standard Deviation 0.3324
|
PRIMARY outcome
Timeframe: Weeks 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Erythrocytes From Baseline
week 1
|
-0.091 10^12 Erythrocytes /L
Standard Deviation 0.1603
|
-0.067 10^12 Erythrocytes /L
Standard Deviation 0.2342
|
-0.037 10^12 Erythrocytes /L
Standard Deviation 0.1574
|
-0.0158 10^12 Erythrocytes /L
Standard Deviation 0.2014
|
-0.066 10^12 Erythrocytes /L
Standard Deviation 0.2763
|
-0.074 10^12 Erythrocytes /L
Standard Deviation 0.1644
|
|
Change in Erythrocytes From Baseline
week 2
|
0.001 10^12 Erythrocytes /L
Standard Deviation 0.01757
|
-0.093 10^12 Erythrocytes /L
Standard Deviation 0.220
|
-0.037 10^12 Erythrocytes /L
Standard Deviation 0.2251
|
-0.084 10^12 Erythrocytes /L
Standard Deviation 0.1660
|
-0.073 10^12 Erythrocytes /L
Standard Deviation 0.2447
|
-0.149 10^12 Erythrocytes /L
Standard Deviation 0.0896
|
|
Change in Erythrocytes From Baseline
week 4
|
-0.065 10^12 Erythrocytes /L
Standard Deviation 0.2011
|
-0.059 10^12 Erythrocytes /L
Standard Deviation 0.2081
|
-0.039 10^12 Erythrocytes /L
Standard Deviation 0.2599
|
-0.059 10^12 Erythrocytes /L
Standard Deviation 0.2024
|
-0.119 10^12 Erythrocytes /L
Standard Deviation 0.2456
|
-0.079 10^12 Erythrocytes /L
Standard Deviation 0.1122
|
|
Change in Erythrocytes From Baseline
week 8
|
0.026 10^12 Erythrocytes /L
Standard Deviation 0.2133
|
0.002 10^12 Erythrocytes /L
Standard Deviation 0.2320
|
0.047 10^12 Erythrocytes /L
Standard Deviation 0.3186
|
-0.024 10^12 Erythrocytes /L
Standard Deviation 0.2767
|
-0.061 10^12 Erythrocytes /L
Standard Deviation 0.3035
|
-0.034 10^12 Erythrocytes /L
Standard Deviation 0.1874
|
|
Change in Erythrocytes From Baseline
week 12
|
0.054 10^12 Erythrocytes /L
Standard Deviation 0.1722
|
-0.036 10^12 Erythrocytes /L
Standard Deviation 0.3260
|
0.027 10^12 Erythrocytes /L
Standard Deviation 0.3375
|
-0.013 10^12 Erythrocytes /L
Standard Deviation 0.2587
|
-0.045 10^12 Erythrocytes /L
Standard Deviation 0.2680
|
-0.070 10^12 Erythrocytes /L
Standard Deviation 0.1488
|
|
Change in Erythrocytes From Baseline
week 24
|
0.007 10^12 Erythrocytes /L
Standard Deviation 0.2073
|
-0.046 10^12 Erythrocytes /L
Standard Deviation 0.2601
|
0.001 10^12 Erythrocytes /L
Standard Deviation 0.2936
|
0.018 10^12 Erythrocytes /L
Standard Deviation 0.2453
|
-0.058 10^12 Erythrocytes /L
Standard Deviation 0.2505
|
-0.062 10^12 Erythrocytes /L
Standard Deviation 0.1691
|
PRIMARY outcome
Timeframe: Weeks 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Hematocrit From Baseline
week 1
|
-1.16 percentage of Total
Standard Deviation 1.446
|
-0.50 percentage of Total
Standard Deviation 2.429
|
-0.35 percentage of Total
Standard Deviation 1.280
|
-1.81 percentage of Total
Standard Deviation 2.05
|
-1.38 percentage of Total
Standard Deviation 2.155
|
-0.59 percentage of Total
Standard Deviation 1.499
|
|
Change in Hematocrit From Baseline
week 2
|
-0.19 percentage of Total
Standard Deviation 1.552
|
-0.49 percentage of Total
Standard Deviation 2.086
|
-0.33 percentage of Total
Standard Deviation 1.991
|
-0.52 percentage of Total
Standard Deviation 2.004
|
-0.80 percentage of Total
Standard Deviation 2.267
|
-1.47 percentage of Total
Standard Deviation 0.647
|
|
Change in Hematocrit From Baseline
week 4
|
-0.59 percentage of Total
Standard Deviation 1.492
|
-0.41 percentage of Total
Standard Deviation 2.004
|
0.15 percentage of Total
Standard Deviation 2.091
|
-0.41 percentage of Total
Standard Deviation 2.339
|
-1.26 percentage of Total
Standard Deviation 2.160
|
-0.78 percentage of Total
Standard Deviation 0.986
|
|
Change in Hematocrit From Baseline
week 8
|
0.26 percentage of Total
Standard Deviation 1.950
|
.047 percentage of Total
Standard Deviation 2.132
|
0.85 percentage of Total
Standard Deviation 2.857
|
-0.04 percentage of Total
Standard Deviation 2.790
|
-0.91 percentage of Total
Standard Deviation 2.775
|
0.05 percentage of Total
Standard Deviation 2.017
|
|
Change in Hematocrit From Baseline
week 12
|
0.31 percentage of Total
Standard Deviation 1.594
|
-0.32 percentage of Total
Standard Deviation 3.175
|
0.61 percentage of Total
Standard Deviation 2.312
|
-0.13 percentage of Total
Standard Deviation 2.819
|
-0.49 percentage of Total
Standard Deviation 2.511
|
-0.59 percentage of Total
Standard Deviation 1.470
|
|
Change in Hematocrit From Baseline
week 24
|
0.21 percentage of Total
Standard Deviation 1.758
|
-0.29 percentage of Total
Standard Deviation 2.534
|
0.62 percentage of Total
Standard Deviation 2.020
|
0.32 percentage of Total
Standard Deviation 2.511
|
-0.81 percentage of Total
Standard Deviation 2.255
|
-0.79 percentage of Total
Standard Deviation 1.389
|
PRIMARY outcome
Timeframe: Weeks 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Platelets From Baseline
week 1
|
7.7 10^9 Platelets /L
Standard Deviation 19.56
|
-0.1 10^9 Platelets /L
Standard Deviation 24.38
|
1.5 10^9 Platelets /L
Standard Deviation 27.38
|
-3.2 10^9 Platelets /L
Standard Deviation 16.20
|
-8.1 10^9 Platelets /L
Standard Deviation 12.15
|
2.3 10^9 Platelets /L
Standard Deviation 21.86
|
|
Change in Platelets From Baseline
week 2
|
17.4 10^9 Platelets /L
Standard Deviation 25.92
|
10.5 10^9 Platelets /L
Standard Deviation 33.06
|
20.3 10^9 Platelets /L
Standard Deviation 24.62
|
4.6 10^9 Platelets /L
Standard Deviation 17.77
|
2.7 10^9 Platelets /L
Standard Deviation 16.23
|
6.5 10^9 Platelets /L
Standard Deviation 14.79
|
|
Change in Platelets From Baseline
week 4
|
4.3 10^9 Platelets /L
Standard Deviation 22.90
|
-0.2 10^9 Platelets /L
Standard Deviation 22.27
|
6.1 10^9 Platelets /L
Standard Deviation 24.28
|
-0.1 10^9 Platelets /L
Standard Deviation 22.93
|
-1.8 10^9 Platelets /L
Standard Deviation 17.76
|
6.2 10^9 Platelets /L
Standard Deviation 16.23
|
|
Change in Platelets From Baseline
week 8
|
11.0 10^9 Platelets /L
Standard Deviation 22.90
|
8.2 10^9 Platelets /L
Standard Deviation 31.41
|
14.2 10^9 Platelets /L
Standard Deviation 23.86
|
-3.8 10^9 Platelets /L
Standard Deviation 24.07
|
2.0 10^9 Platelets /L
Standard Deviation 14.11
|
9.4 10^9 Platelets /L
Standard Deviation 28.11
|
|
Change in Platelets From Baseline
week 12
|
15.9 10^9 Platelets /L
Standard Deviation 31.26
|
6.0 10^9 Platelets /L
Standard Deviation 30.25
|
13.3 10^9 Platelets /L
Standard Deviation 27.51
|
-7.1 10^9 Platelets /L
Standard Deviation 21.05
|
-6.3 10^9 Platelets /L
Standard Deviation 16.19
|
0.1 10^9 Platelets /L
Standard Deviation 17.94
|
|
Change in Platelets From Baseline
week 24
|
11.3 10^9 Platelets /L
Standard Deviation 30.27
|
11.3 10^9 Platelets /L
Standard Deviation 36.34
|
5.9 10^9 Platelets /L
Standard Deviation 18.30
|
-2.7 10^9 Platelets /L
Standard Deviation 31.25
|
1.9 10^9 Platelets /L
Standard Deviation 19.30
|
-4.4 10^9 Platelets /L
Standard Deviation 24.42
|
PRIMARY outcome
Timeframe: Weeks 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Hemoglobin From Baseline
week 1
|
-3.6 g/L
Standard Deviation 5.21
|
-2.1 g/L
Standard Deviation 6.31
|
-2.3 g/L
Standard Deviation 4.89
|
-4.5 g/L
Standard Deviation 5.70
|
-1.7 g/L
Standard Deviation 7.07
|
-2.2 g/L
Standard Deviation 4.44
|
|
Change in Hemoglobin From Baseline
week 2
|
-0.8 g/L
Standard Deviation 5.54
|
-2.6 g/L
Standard Deviation 6.33
|
-2.8 g/L
Standard Deviation 6.14
|
-3.3 g/L
Standard Deviation 5.51
|
-2.1 g/L
Standard Deviation 7.45
|
-3.0 g/L
Standard Deviation 3.25
|
|
Change in Hemoglobin From Baseline
week 4
|
-2.3 g/L
Standard Deviation 5.86
|
-4.8 g/L
Standard Deviation 6.05
|
-5.8 g/L
Standard Deviation 6.66
|
-1.6 g/L
Standard Deviation 6.55
|
-1.9 g/L
Standard Deviation 7.52
|
1.5 g/L
Standard Deviation 5.01
|
|
Change in Hemoglobin From Baseline
week 8
|
3.5 g/L
Standard Deviation 6.15
|
-2.9 g/L
Standard Deviation 6.61
|
-0.9 g/L
Standard Deviation 8.20
|
0.3 g/L
Standard Deviation 7.84
|
-1.6 g/L
Standard Deviation 9.45
|
2.4 g/L
Standard Deviation 4.87
|
|
Change in Hemoglobin From Baseline
week 12
|
-2.0 g/L
Standard Deviation 4.93
|
-2.6 g/L
Standard Deviation 8.94
|
0.1 g/L
Standard Deviation 8.71
|
1.8 g/L
Standard Deviation 8.07
|
0.6 g/L
Standard Deviation 7.89
|
0.3 g/L
Standard Deviation 5.74
|
|
Change in Hemoglobin From Baseline
week 24
|
-0.8 g/L
Standard Deviation 6.13
|
-3.1 g/L
Standard Deviation 7.55
|
0.1 g/L
Standard Deviation 8.09
|
2.8 g/L
Standard Deviation 6.97
|
-0.2 g/L
Standard Deviation 7.88
|
-0.1 g/L
Standard Deviation 5.45
|
PRIMARY outcome
Timeframe: week 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Sodium From Baseline
week 1
|
-0.1 mmol/L
Standard Deviation 1.33
|
0.6 mmol/L
Standard Deviation 2.06
|
0.3 mmol/L
Standard Deviation 2.29
|
0.3 mmol/L
Standard Deviation 1.65
|
0.6 mmol/L
Standard Deviation 1.92
|
1.8 mmol/L
Standard Deviation 1.97
|
|
Change in Sodium From Baseline
week 2
|
0.6 mmol/L
Standard Deviation 1.72
|
0.4 mmol/L
Standard Deviation 2.32
|
0.3 mmol/L
Standard Deviation 1.79
|
0.3 mmol/L
Standard Deviation 221
|
-0.5 mmol/L
Standard Deviation 1.85
|
1.5 mmol/L
Standard Deviation 1.96
|
|
Change in Sodium From Baseline
week 4
|
0.5 mmol/L
Standard Deviation 1.36
|
-1.6 mmol/L
Standard Deviation 1.96
|
0.1 mmol/L
Standard Deviation 1.39
|
-1.1 mmol/L
Standard Deviation 1.18
|
0.6 mmol/L
Standard Deviation 1.92
|
0.8 mmol/L
Standard Deviation 2.21
|
|
Change in Sodium From Baseline
week 8
|
0.0 mmol/L
Standard Deviation 1.56
|
-0.5 mmol/L
Standard Deviation 1.81
|
-0.1 mmol/L
Standard Deviation 2.03
|
-0.7 mmol/L
Standard Deviation 182
|
0.5 mmol/L
Standard Deviation 2.07
|
0.3 mmol/L
Standard Deviation 2.26
|
|
Change in Sodium From Baseline
week 12
|
-0.2 mmol/L
Standard Deviation 1.37
|
-0.9 mmol/L
Standard Deviation 1.25
|
1.1 mmol/L
Standard Deviation 2.31
|
-0.8 mmol/L
Standard Deviation 1.84
|
-0.2 mmol/L
Standard Deviation 2.11
|
1.8 mmol/L
Standard Deviation 1.47
|
|
Change in Sodium From Baseline
week 24
|
0.8 mmol/L
Standard Deviation 1.86
|
-0.3 mmol/L
Standard Deviation 2.19
|
1.8 mmol/L
Standard Deviation 2.01
|
0.1 mmol/L
Standard Deviation 1.85
|
0.9 mmol/L
Standard Deviation 1.85
|
2.1 mmol/L
Standard Deviation 2.14
|
PRIMARY outcome
Timeframe: week 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Potassium From Baseline
week 1
|
0.125 mmol/L
Standard Deviation 0.3070
|
-0.007 mmol/L
Standard Deviation 0.3696
|
0.189 mmol/L
Standard Deviation 0.4025
|
0.036 mmol/L
Standard Deviation 0.3269
|
0.239 mmol/L
Standard Deviation 0.5699
|
-0.158 mmol/L
Standard Deviation 0.3481
|
|
Change in Potassium From Baseline
week 2
|
0.057 mmol/L
Standard Deviation 0.2369
|
-0.037 mmol/L
Standard Deviation 0.2778
|
0.064 mmol/L
Standard Deviation 0.2900
|
-0.049 mmol/L
Standard Deviation 0.4433
|
-0.137 mmol/L
Standard Deviation 0.4979
|
-0.089 mmol/L
Standard Deviation 0.3626
|
|
Change in Potassium From Baseline
week 4
|
0.036 mmol/L
Standard Deviation 0.3004
|
-0.195 mmol/L
Standard Deviation 0.2952
|
0.113 mmol/L
Standard Deviation 0.34446
|
0.023 mmol/L
Standard Deviation 0.4688
|
-0.023 mmol/L
Standard Deviation 0.4196
|
-0.227 mmol/L
Standard Deviation 0.3090
|
|
Change in Potassium From Baseline
week 8
|
-0.028 mmol/L
Standard Deviation 0.3874
|
0.045 mmol/L
Standard Deviation 0.3680
|
0.241 mmol/L
Standard Deviation 0.3395
|
-0.008 mmol/L
Standard Deviation 0.4328
|
0.271 mmol/L
Standard Deviation 0.3383
|
-0.209 mmol/L
Standard Deviation 0.3582
|
|
Change in Potassium From Baseline
week 12
|
0.040 mmol/L
Standard Deviation 0.4153
|
-0.205 mmol/L
Standard Deviation 0.4556
|
0.217 mmol/L
Standard Deviation 0.2773
|
0.072 mmol/L
Standard Deviation 0.3896
|
0.089 mmol/L
Standard Deviation 0.2322
|
-0.110 mmol/L
Standard Deviation 0.2961
|
|
Change in Potassium From Baseline
week 24
|
0.061 mmol/L
Standard Deviation 0.2474
|
0.161 mmol/L
Standard Deviation 0.2367
|
0.324 mmol/L
Standard Deviation 0.2924
|
0.023 mmol/L
Standard Deviation 0.2988
|
0.253 mmol/L
Standard Deviation 0.410
|
-0.190 mmol/L
Standard Deviation 0.3313
|
PRIMARY outcome
Timeframe: week 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Alkaline Phosphatase From Baseline
week 1
|
2.1 U/L
Standard Deviation 7.52
|
0.7 U/L
Standard Deviation 4.92
|
-3.7 U/L
Standard Deviation 6.52
|
-4.9 U/L
Standard Deviation 4.89
|
-0.7 U/L
Standard Deviation 6.76
|
0.9 U/L
Standard Deviation 6.94
|
|
Change in Alkaline Phosphatase From Baseline
week 2
|
0.5 U/L
Standard Deviation 7.06
|
2.0 U/L
Standard Deviation 6.63
|
-4.7 U/L
Standard Deviation 6.43
|
-1.8 U/L
Standard Deviation 5.39
|
-4.3 U/L
Standard Deviation 5.61
|
0.3 U/L
Standard Deviation 7.62
|
|
Change in Alkaline Phosphatase From Baseline
week 4
|
1.3 U/L
Standard Deviation 9.62
|
-0.4 U/L
Standard Deviation 5.74
|
3.6 U/L
Standard Deviation 7.52
|
-2.4 U/L
Standard Deviation 6.31
|
-2.7 U/L
Standard Deviation 6.60
|
3.2 U/L
Standard Deviation 4.21
|
|
Change in Alkaline Phosphatase From Baseline
week 8
|
5.0 U/L
Standard Deviation 6.31
|
2.5 U/L
Standard Deviation 5.36
|
1.1 U/L
Standard Deviation 6.35
|
-2.4 U/L
Standard Deviation 5.94
|
3.5 U/L
Standard Deviation 6.24
|
4.1 U/L
Standard Deviation 5.65
|
|
Change in Alkaline Phosphatase From Baseline
week 12
|
2.7 U/L
Standard Deviation 11.92
|
3.2 U/L
Standard Deviation 5.91
|
3.9 U/L
Standard Deviation 7.81
|
-1.1 U/L
Standard Deviation 5.48
|
-2.1 U/L
Standard Deviation 10.02
|
0.1 U/L
Standard Deviation 6.02
|
|
Change in Alkaline Phosphatase From Baseline
week 24
|
1.7 U/L
Standard Deviation 8.17
|
5.3 U/L
Standard Deviation 9.49
|
3.3 U/L
Standard Deviation 9.50
|
-1.7 U/L
Standard Deviation 7.01
|
2.1 U/L
Standard Deviation 11.48
|
2.3 U/L
Standard Deviation 8.48
|
PRIMARY outcome
Timeframe: week 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Alanine Aminotransferase From Baseline
week 1
|
1.3 U/L
Standard Deviation 6.69
|
2.3 U/L
Standard Deviation 6.33
|
-0.2 U/L
Standard Deviation 2.91
|
-1.8 U/L
Standard Deviation 2.44
|
4.3 U/L
Standard Deviation 20.30
|
0.2 U/L
Standard Deviation 3.55
|
|
Change in Alanine Aminotransferase From Baseline
week 2
|
2.7 U/L
Standard Deviation 16.39
|
2.0 U/L
Standard Deviation 5.13
|
2.5 U/L
Standard Deviation 5.25
|
-1.1 U/L
Standard Deviation 3.26
|
2.6 U/L
Standard Deviation 3.98
|
0.9 U/L
Standard Deviation 3.68
|
|
Change in Alanine Aminotransferase From Baseline
week 4
|
1.1 U/L
Standard Deviation 10.91
|
2.9 U/L
Standard Deviation 3.81
|
0.9 U/L
Standard Deviation 6.65
|
0.9 U/L
Standard Deviation 3.96
|
0.1 U/L
Standard Deviation 3.84
|
0.7 U/L
Standard Deviation 4.43
|
|
Change in Alanine Aminotransferase From Baseline
week 8
|
1.2 U/L
Standard Deviation 12.13
|
4.1 U/L
Standard Deviation 6.08
|
0.1 U/L
Standard Deviation 5.46
|
-1.4 U/L
Standard Deviation 5.26
|
0.8 U/L
Standard Deviation 7.02
|
-0.1 U/L
Standard Deviation 2.99
|
|
Change in Alanine Aminotransferase From Baseline
week 12
|
6.9 U/L
Standard Deviation 12.59
|
4.9 U/L
Standard Deviation 6.33
|
3.9 U/L
Standard Deviation 9.84
|
-0.5 U/L
Standard Deviation 8.22
|
0.4 U/L
Standard Deviation 3.76
|
-1.1 U/L
Standard Deviation 3.23
|
|
Change in Alanine Aminotransferase From Baseline
week 24
|
-0.7 U/L
Standard Deviation 11.81
|
1.2 U/L
Standard Deviation 4.20
|
0.3 U/L
Standard Deviation 10.26
|
10. U/L
Standard Deviation 3.38
|
-0.3 U/L
Standard Deviation 6.31
|
-0.9 U/L
Standard Deviation 3.83
|
PRIMARY outcome
Timeframe: week 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Aspartate Aminotransferase From Baseline
week 1
|
-1.60 U/L
Standard Deviation 4.982
|
0.40 U/L
Standard Deviation 4.768
|
-0.40 U/L
Standard Deviation 2.898
|
-1.38 U/L
Standard Deviation 4.530
|
3.93 U/L
Standard Deviation 11.738
|
-1.33 U/L
Standard Deviation 2.380
|
|
Change in Aspartate Aminotransferase From Baseline
week 2
|
9.07 U/L
Standard Deviation 32.288
|
0.29 U/L
Standard Deviation 3.106
|
2.27 U/L
Standard Deviation 3.262
|
-2.44 U/L
Standard Deviation 5.151
|
0.07 U/L
Standard Deviation 3.150
|
-0.80 U/L
Standard Deviation 3.649
|
|
Change in Aspartate Aminotransferase From Baseline
week 4
|
-0.13 U/L
Standard Deviation 4.518
|
2.53 U/L
Standard Deviation 3.067
|
0.87 U/L
Standard Deviation 4.015
|
0.69 U/L
Standard Deviation 4.191
|
1.47 U/L
Standard Deviation 3.720
|
-0.93 U/L
Standard Deviation 3.240
|
|
Change in Aspartate Aminotransferase From Baseline
week 8
|
1.07 U/L
Standard Deviation 4.480
|
1.20 U/L
Standard Deviation 5.735
|
1.13 U/L
Standard Deviation 3.623
|
-2.50 U/L
Standard Deviation 4.487
|
1.13 U/L
Standard Deviation 4.340
|
-0.93 U/L
Standard Deviation 3.411
|
|
Change in Aspartate Aminotransferase From Baseline
week 12
|
2.73 U/L
Standard Deviation 6.147
|
2.47 U/L
Standard Deviation 4.533
|
2.20 U/L
Standard Deviation 4.109
|
.194 U/L
Standard Deviation 4.106
|
-0.20 U/L
Standard Deviation 3.986
|
0.13 U/L
Standard Deviation 3.739
|
|
Change in Aspartate Aminotransferase From Baseline
week 24
|
0.33 U/L
Standard Deviation 6.091
|
0.87 U/L
Standard Deviation 2.774
|
0.07 U/L
Standard Deviation 5.391
|
-1.53 U/L
Standard Deviation 4.357
|
4.27 U/L
Standard Deviation 18.763
|
-0.29 U/L
Standard Deviation 3.384
|
PRIMARY outcome
Timeframe: week 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Direct Bilirubin Form Baseline
week 1
|
0.1026 umol/L
Standard Deviation 0.9712
|
-0.3420 umol/L
Standard Deviation 0.9950
|
-0.2622 umol/L
Standard Deviation 1.5375
|
-0.0214 umol/L
Standard Deviation 1.0992
|
0.2280 umol/L
Standard Deviation 0.8878
|
0.2280 umol/L
Standard Deviation 0.8419
|
|
Change in Direct Bilirubin Form Baseline
week 2
|
0.4140 umol/L
Standard Deviation 0.8857
|
4.5942 umol/L
Standard Deviation 17.8620
|
-0.1482 umol/L
Standard Deviation 1.1559
|
-0.1603 umol/L
Standard Deviation 0.6767
|
-0.0684 umol/L
Standard Deviation 0.05040
|
-0.0570 umol/L
Standard Deviation 0.7129
|
|
Change in Direct Bilirubin Form Baseline
week 4
|
0.1140 umol/L
Standard Deviation 0.7907
|
0.3762 umol/L
Standard Deviation 0.9053
|
-0.1710 umol/L
Standard Deviation 1.6503
|
-0.0107 umol/L
Standard Deviation 0.7835
|
0.0570 umol/L
Standard Deviation 0.7331
|
-0.1254 umol/L
Standard Deviation 0.8802
|
|
Change in Direct Bilirubin Form Baseline
week 8
|
0.6498 umol/L
Standard Deviation 0.8155
|
0.2394 umol/L
Standard Deviation 0.9362
|
-0.1026 umol/L
Standard Deviation 1.8449
|
0.0962 umol/L
Standard Deviation 1.1945
|
0.0570 umol/L
Standard Deviation 0.8783
|
0.1140 umol/L
Standard Deviation 0.6452
|
|
Change in Direct Bilirubin Form Baseline
week 12
|
0.4789 umol/L
Standard Deviation 1.4059
|
0.1938 umol/L
Standard Deviation 0.9209
|
-0.3534 umol/L
Standard Deviation 1.3718
|
-0.1603 umol/L
Standard Deviation 0.8365
|
-0.6270 umol/L
Standard Deviation 0.7720
|
-0.0228 umol/L
Standard Deviation 0.8547
|
|
Change in Direct Bilirubin Form Baseline
week 24
|
0.0114 umol/L
Standard Deviation 0.8610
|
0.0689 umol/L
Standard Deviation 0.9883
|
-0.1482 umol/L
Standard Deviation 2.1081
|
0.1254 umol/L
Standard Deviation 0.9531
|
-0.0342 umol/L
Standard Deviation 1.2181
|
0.1710 umol/L
Standard Deviation 0.6938
|
PRIMARY outcome
Timeframe: week 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Bilirubin From Baseline
week 1
|
0.3534 umol/L
Standard Deviation 3.7254
|
-1.1970 umol/L
Standard Deviation 3.7725
|
0.1048 umol/L
Standard Deviation 5.4294
|
0.0641 umol/L
Standard Deviation 4.2155
|
-0.0228 umol/L
Standard Deviation 3.5705
|
0.5586 umol/L
Standard Deviation 2.8697
|
|
Change in Bilirubin From Baseline
week 2
|
1.1286 umol/L
Standard Deviation 3.4315
|
-0.1938 umol/L
Standard Deviation 3.5435
|
-0.1824 umol/L
Standard Deviation 4.4841
|
-0.4275 umol/L
Standard Deviation 2.54871
|
-0.7980 umol/L
Standard Deviation 1.7181
|
-0.7069 umol/L
Standard Deviation 2.5436
|
|
Change in Bilirubin From Baseline
week 4
|
-0.7068 umol/L
Standard Deviation 3.0527
|
1.0146 umol/L
Standard Deviation 3.526
|
-0.2736 umol/L
Standard Deviation 6.4174
|
0.1176 umol/L
Standard Deviation 2.9557
|
-0.0456 umol/L
Standard Deviation 2.7064
|
-0.6954 umol/L
Standard Deviation 2.9706
|
|
Change in Bilirubin From Baseline
week 8
|
2.1546 umol/L
Standard Deviation 3.7037
|
0.2280 umol/L
Standard Deviation 3.2820
|
0.2052 umol/L
Standard Deviation 7.1427
|
0.0534 umol/L
Standard Deviation 3.9465
|
-0.5244 umol/L
Standard Deviation 3.0702
|
-0.3192 umol/L
Standard Deviation 1.9269
|
|
Change in Bilirubin From Baseline
week 12
|
1.9038 umol/L
Standard Deviation 6.9092
|
0.3078 umol/L
Standard Deviation 3.7354
|
-0.6954 umol/L
Standard Deviation 5.6701
|
-1.1222 umol/L
Standard Deviation 2.5108
|
-2.6220 umol/L
Standard Deviation 2.8960
|
-0.3420 umol/L
Standard Deviation 3.1431
|
|
Change in Bilirubin From Baseline
week 24
|
-0.7524 umol/L
Standard Deviation 2.8223
|
0.05586 umol/L
Standard Deviation 3.9258
|
23.9286 umol/L
Standard Deviation 91.7547
|
-0.0114 umol/L
Standard Deviation 3.4670
|
-0.3078 umol/L
Standard Deviation 4.4235
|
-0.1954 umol/L
Standard Deviation 2.9227
|
PRIMARY outcome
Timeframe: week 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Albumin Form Baseline
week 1
|
-2.45 g/L
Standard Deviation 2.989
|
-0.65 g/L
Standard Deviation 2.370
|
-1.70 g/L
Standard Deviation 2.6376
|
-1.67 g/L
Standard Deviation 2.775
|
0.03 g/L
Standard Deviation 2.343
|
-0.64 g/L
Standard Deviation 2.346
|
|
Change in Albumin Form Baseline
week 2
|
-0.01 g/L
Standard Deviation 2.334
|
-0.83 g/L
Standard Deviation 3.253
|
-1.37 g/L
Standard Deviation 2.943
|
-1.03 g/L
Standard Deviation 1.1885
|
-0.73 g/L
Standard Deviation 2.504
|
-1.61 g/L
Standard Deviation 1.739
|
|
Change in Albumin Form Baseline
week 4
|
0.62 g/L
Standard Deviation 3.150
|
-159 g/L
Standard Deviation 2.035
|
-0.08 g/L
Standard Deviation 2.486
|
-1.00 g/L
Standard Deviation 2.055
|
-1.53 g/L
Standard Deviation 2.707
|
-0.87 g/L
Standard Deviation 2.408
|
|
Change in Albumin Form Baseline
week 8
|
-0.23 g/L
Standard Deviation 2.666
|
-2.07 g/L
Standard Deviation 2.587
|
0.71 g/L
Standard Deviation 2.619
|
-1.47 g/L
Standard Deviation 2.587
|
-2.43 g/L
Standard Deviation 2.880
|
-0.45 g/L
Standard Deviation 2.770
|
|
Change in Albumin Form Baseline
week 12
|
-0.86 g/L
Standard Deviation 2.442
|
-1.68 g/L
Standard Deviation 2.815
|
-0.25 g/L
Standard Deviation 2.167
|
-0.64 g/L
Standard Deviation 2.2143
|
-0.93 g/L
Standard Deviation 1.617
|
-0.13 g/L
Standard Deviation 1.848
|
|
Change in Albumin Form Baseline
week 24
|
-0.62 g/L
Standard Deviation 2.155
|
-2.56 g/L
Standard Deviation 2.201
|
-1.59 g/L
Standard Deviation 2.630
|
-1.21 g/L
Standard Deviation 2.811
|
-0.07 g/L
Standard Deviation 3.501
|
1.21 g/L
Standard Deviation 2.598
|
PRIMARY outcome
Timeframe: week 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Creatinine Form Baseline
week 1
|
-0.6483 umol/L
Standard Deviation 5.2878
|
-2.9467 umol/L
Standard Deviation 5.8701
|
1.4733 umol/L
Standard Deviation 3.9908
|
-4.0333 umol/L
Standard Deviation 8.5827
|
1.2963 umol/L
Standard Deviation 9.553
|
-0.5304 umol/L
Standard Deviation 7.3491
|
|
Change in Creatinine Form Baseline
week 2
|
1.5323 umol/L
Standard Deviation 5.3404
|
-2.1805 umol/L
Standard Deviation 4.9992
|
2.1216 umol/L
Standard Deviation 37176
|
0.3315 umol/L
Standard Deviation 7.9125
|
0.3536 umol/L
Standard Deviation 5.9657
|
-1.3555 umol/L
Standard Deviation 6.7561
|
|
Change in Creatinine Form Baseline
week 4
|
-2.3575 umol/L
Standard Deviation 4.4284
|
-4.2432 umol/L
Standard Deviation 4.7511
|
1.6501 umol/L
Standard Deviation 5.2284
|
-2.4310 umol/L
Standard Deviation 8.9600
|
-1.8959 umol/L
Standard Deviation 6.6394
|
-1.7680 umol/L
Standard Deviation 5.9017
|
|
Change in Creatinine Form Baseline
week 8
|
2.2116 umol/L
Standard Deviation 6.3904
|
-0.3536 umol/L
Standard Deviation 5.6088
|
2.4163 umol/L
Standard Deviation 3.0889
|
-3.228 umol/L
Standard Deviation 8.9278
|
-1.5912 umol/L
Standard Deviation 4.6442
|
-2.1216 umol/L
Standard Deviation 5.4779
|
|
Change in Creatinine Form Baseline
week 12
|
0.5893 umol/L
Standard Deviation 6.8610
|
-2.8288 umol/L
Standard Deviation 5.5929
|
1.1787 umol/L
Standard Deviation 3.2680
|
-3.0940 umol/L
Standard Deviation 10.4097
|
-4.4789 umol/L
Standard Deviation 6.7279
|
-3.2413 umol/L
Standard Deviation 5.6175
|
|
Change in Creatinine Form Baseline
week 24
|
-4.9504 umol/L
Standard Deviation 5.6088
|
-2.0037 umol/L
Standard Deviation 4.6112
|
-0.11799 umol/L
Standard Deviation 5.382
|
-4.2432 umol/L
Standard Deviation 9.2244
|
-3.1824 umol/L
Standard Deviation 5.9751
|
-1.6417 umol/L
Standard Deviation 7.1888
|
PRIMARY outcome
Timeframe: week 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Lactate Dehydrogenase From Baseline
week 1
|
-3.5 U/L
Standard Deviation 12.69
|
0.5 U/L
Standard Deviation 20.00
|
6.5 U/L
Standard Deviation 15.62
|
-10.8 U/L
Standard Deviation 17.09
|
-2.6 U/L
Standard Deviation 19.82
|
0.9 U/L
Standard Deviation 14.11
|
|
Change in Lactate Dehydrogenase From Baseline
week 2
|
8.4 U/L
Standard Deviation 35.25
|
1.4 U/L
Standard Deviation 21.89
|
7.3 U/L
Standard Deviation 17.99
|
-7.0 U/L
Standard Deviation 20.64
|
-10.9 U/L
Standard Deviation 13.17
|
-5.7 U/L
Standard Deviation 16.18
|
|
Change in Lactate Dehydrogenase From Baseline
week 4
|
-3.0 U/L
Standard Deviation 16.46
|
-1.7 U/L
Standard Deviation 18.67
|
5.1 U/L
Standard Deviation 15.34
|
2.1 U/L
Standard Deviation 12.37
|
1.3 U/L
Standard Deviation 17.54
|
-3.9 U/L
Standard Deviation 19.78
|
|
Change in Lactate Dehydrogenase From Baseline
week 8
|
-4.3 U/L
Standard Deviation 10.31
|
-2.4 U/L
Standard Deviation 16.82
|
14.2 U/L
Standard Deviation 24.40
|
-11.2 U/L
Standard Deviation 17.86
|
3.7 U/L
Standard Deviation 37.19
|
-4.2 U/L
Standard Deviation 17.31
|
|
Change in Lactate Dehydrogenase From Baseline
week 12
|
-9.1 U/L
Standard Deviation 13.48
|
-3.8 U/L
Standard Deviation 20.23
|
1.3 U/L
Standard Deviation 16.86
|
-10.1 U/L
Standard Deviation 17.55
|
-8.9 U/L
Standard Deviation 15.95
|
-3.4 U/L
Standard Deviation 23.85
|
|
Change in Lactate Dehydrogenase From Baseline
week 24
|
-9.4 U/L
Standard Deviation 18.26
|
-3.3 U/L
Standard Deviation 20.58
|
-2.1 U/L
Standard Deviation 12.06
|
-10.0 U/L
Standard Deviation 19.42
|
-3.1 U/L
Standard Deviation 22.96
|
2.4 U/L
Standard Deviation 25.13
|
PRIMARY outcome
Timeframe: week 1,2,4,8,12, and 24Outcome measures
| Measure |
Arm 1 - Low Dose
n=15 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Change in Urea Nitrogen From Baseline
week 1
|
0.0571 mmol/L
Standard Deviation 1.9802
|
0.0524 mmol/L
Standard Deviation 1.5732
|
-0.5712 mmol/L
Standard Deviation 2.7988
|
0.1428 mmol/L
Standard Deviation 2.0927
|
-0.4712 mmol/L
Standard Deviation 1.5268
|
-0.3237 mmol/L
Standard Deviation 2.4570
|
|
Change in Urea Nitrogen From Baseline
week 2
|
0.2951 mmol/L
Standard Deviation 1.9132
|
0.5284 mmol/L
Standard Deviation 2.2289
|
-0.9377 mmol/L
Standard Deviation 3.3246
|
-0.2365 mmol/L
Standard Deviation 2.2977
|
0.7854 mmol/L
Standard Deviation 1.2804
|
-0.6378 mmol/L
Standard Deviation 2.4125
|
|
Change in Urea Nitrogen From Baseline
week 4
|
0.1571 mmol/L
Standard Deviation 2.2931
|
-0.1856 mmol/L
Standard Deviation 1.6149
|
-0.1428 mmol/L
Standard Deviation 2.3668
|
-0.3570 mmol/L
Standard Deviation 2.0358
|
-0.6474 mmol/L
Standard Deviation 1.8290
|
-0.5807 mmol/L
Standard Deviation 2.3925
|
|
Change in Urea Nitrogen From Baseline
week 8
|
-0.4522 mmol/L
Standard Deviation 2.0612
|
-0.0286 mmol/L
Standard Deviation 1.5584
|
-0.0952 mmol/L
Standard Deviation 2.322
|
-0.0759 mmol/L
Standard Deviation 2.3484
|
-1.0900 mmol/L
Standard Deviation 2.3572
|
0.3237 mmol/L
Standard Deviation 2.1001
|
|
Change in Urea Nitrogen From Baseline
week 12
|
-0.0143 mmol/L
Standard Deviation 1.8835
|
0.1000 mmol/L
Standard Deviation 2.1727
|
-0.6045 mmol/L
Standard Deviation 2.6703
|
0.3525 mmol/L
Standard Deviation 2.3561
|
-0.4667 mmol/L
Standard Deviation 2.1063
|
-0.6426 mmol/L
Standard Deviation 1.9342
|
|
Change in Urea Nitrogen From Baseline
week 24
|
-0.0619 mmol/L
Standard Deviation 1.7148
|
0.2667 mmol/L
Standard Deviation 2.8833
|
-0.5331 mmol/L
Standard Deviation 2.3939
|
0.5379 mmol/L
Standard Deviation 2.3910
|
-0.2999 mmol/L
Standard Deviation 1.5902
|
-0.1989 mmol/L
Standard Deviation 2.9145
|
SECONDARY outcome
Timeframe: week 1, 2, 4, 8, 12, and 24Population: * One subject in arm-1 low dose (adult cohort) had an asymptomatic infection around the time of vaccination. This was discovered post hoc, and this subject was excluded from all Immunogenicity Analysis Set(IAS). * One subject in Arm-4 low dose (elderly cohort) had a suspicious non-specific reactivity to the tests and was excluded from the IAS. * Other specification: % = Calculated as nr. of subjects within category divided by nr. of subjects with non-missing observation at each time point.
To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine Immunogenicity Result: Seroconversion for Anti-S Antibody Interpretation: n. of subjects positive, negative or indeterminate at week 1, 2, 4, 8, 12, and 24 after vaccination.
Outcome measures
| Measure |
Arm 1 - Low Dose
n=14 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=15 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 24 · negative
|
4 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
3 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 8 · positive
|
13 Participants
|
14 Participants
|
14 Participants
|
10 Participants
|
12 Participants
|
13 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 8 · negative
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 8 · indeterminate
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 24 · positive
|
10 Participants
|
7 Participants
|
11 Participants
|
6 Participants
|
5 Participants
|
10 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 12 · positive
|
13 Participants
|
13 Participants
|
13 Participants
|
10 Participants
|
11 Participants
|
13 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 12 · negative
|
1 Participants
|
2 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 12 · indeterminate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 1 · positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 1 · negative
|
14 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 1 · indeterminate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 2 · positive
|
8 Participants
|
7 Participants
|
8 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 2 · negative
|
6 Participants
|
7 Participants
|
6 Participants
|
10 Participants
|
7 Participants
|
9 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 2 · indeterminate
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 4 · positive
|
13 Participants
|
14 Participants
|
13 Participants
|
14 Participants
|
14 Participants
|
14 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 4 · negative
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 4 · indeterminate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive, Negative or Indeterminate Seroconversion for Anti-s Antibody
week 24 · indeterminate
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: week 1, 2, 4, 8, 12 and 24Population: * One subject in arm-1 low dose (adult cohort) had an asymptomatic infection around the time of vaccination. This was discovered post hoc, and this subject was excluded from all Immunogenicity Analysis Set(IAS). * One subject in Arm-4 low dose (elderly cohort) had a suspicious non-specific reactivity to the tests and was excluded from the IAS. * Other specification: % = Calculated as nr. of subjects within category divided by nr. of subjects with non-missing observation at each time point.
To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated: anti-N Antibody Interpretation: n. of subjects positive, negative at week 1, 2, 4, 8, 12 and 24 compared to baseline
Outcome measures
| Measure |
Arm 1 - Low Dose
n=14 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=15 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Positive, Negative Anti-n Antibody
week 1 · positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive, Negative Anti-n Antibody
week 1 · negative
|
14 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
|
Number of Participants With Positive, Negative Anti-n Antibody
week 2 · positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive, Negative Anti-n Antibody
week 2 · negative
|
14 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
|
Number of Participants With Positive, Negative Anti-n Antibody
week 4 · positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive, Negative Anti-n Antibody
week 4 · negative
|
14 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
|
Number of Participants With Positive, Negative Anti-n Antibody
week 8 · positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive, Negative Anti-n Antibody
week 8 · negative
|
14 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
|
Number of Participants With Positive, Negative Anti-n Antibody
week 12 · positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive, Negative Anti-n Antibody
week 12 · negative
|
14 Participants
|
15 Participants
|
14 Participants
|
15 Participants
|
15 Participants
|
15 Participants
|
|
Number of Participants With Positive, Negative Anti-n Antibody
week 24 · positive
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Positive, Negative Anti-n Antibody
week 24 · negative
|
14 Participants
|
13 Participants
|
13 Participants
|
12 Participants
|
13 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: week 4 and week 24Population: number of subjects analyzed is calculated based on number of subjects with non missing observation thus numbers of subjects analyzed may vary between the observation period.
To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated: Micro Neutralization test Interpretation: n. of positive and negative subjects at week 4 and week 24 by evaluating geometric mean titer change from baseline
Outcome measures
| Measure |
Arm 1 - Low Dose
n=14 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=15 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Positive, Negative for Micro Neutralization Test
positive week 4
|
6 Participants
|
10 Participants
|
9 Participants
|
12 Participants
|
10 Participants
|
11 Participants
|
|
Number of Participants With Positive, Negative for Micro Neutralization Test
Negative week 4
|
8 Participants
|
5 Participants
|
6 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants With Positive, Negative for Micro Neutralization Test
Positive week 24
|
2 Participants
|
4 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants With Positive, Negative for Micro Neutralization Test
Negative week 24
|
12 Participants
|
9 Participants
|
8 Participants
|
10 Participants
|
9 Participants
|
7 Participants
|
SECONDARY outcome
Timeframe: baseline, week 2, week 4, week 8, week 12, week 24Population: number of subjects analyzed is calculated based on number of subjects with non missing observation thus numbers of subjects analyzed may vary between the observation period.
To assess the cellular and humoral immune response to SARS-CoV2 elicited by the vaccine cellular and humoral immune parameters evaluated. T-cells were evaluated on frozen and fresh (week2) samples Within-cohort comparisons to assess the difference in immune response according to different doses in the same population Across-the-cohort comparison to assess whether elderlies and adults have a different pattern of immune response after vaccination at different endpoints Unit: spot-forming cells \[SFC\]/1 × 10\^6 peripheral blood mononuclear cell \[PBMC\] Interpretation: values higher than at baseline are indicative of a persistent spike-specific memory T-cell establishment.
Outcome measures
| Measure |
Arm 1 - Low Dose
n=14 Participants
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 Participants
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 Participants
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=15 Participants
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 Participants
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 Participants
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
Immunogenicity - T-cell Response
T-cell response baseline
|
54 SFC/1x10^6 PBMC
Interval 23.0 to 88.0
|
88.0 SFC/1x10^6 PBMC
Interval 43.0 to 138.0
|
128.0 SFC/1x10^6 PBMC
Interval 65.0 to 213.0
|
320.0 SFC/1x10^6 PBMC
Interval 78.0 to 760.0
|
165.0 SFC/1x10^6 PBMC
Interval 128.0 to 565.0
|
425.0 SFC/1x10^6 PBMC
Interval 295.0 to 1050.0
|
|
Immunogenicity - T-cell Response
T-cell response week 2 (fresh samples)
|
1161.0 SFC/1x10^6 PBMC
Interval 438.0 to 2430.0
|
2857.0 SFC/1x10^6 PBMC
Interval 412.0 to 4702.0
|
2272.0 SFC/1x10^6 PBMC
Interval 1243.0 to 3568.0
|
1917.0 SFC/1x10^6 PBMC
Interval 1353.0 to 3613.0
|
2262.0 SFC/1x10^6 PBMC
Interval 1228.0 to 3942.0
|
3142.0 SFC/1x10^6 PBMC
Interval 1555.0 to 8265.0
|
|
Immunogenicity - T-cell Response
T-cell response week 2 (frozen samples)
|
1214.0 SFC/1x10^6 PBMC
Interval 465.0 to 1475.0
|
1095.0 SFC/1x10^6 PBMC
Interval 328.0 to 3083.0
|
905.0 SFC/1x10^6 PBMC
Interval 743.0 to 1465.0
|
1258.0 SFC/1x10^6 PBMC
Interval 975.0 to 2790.0
|
1363.0 SFC/1x10^6 PBMC
Interval 570.0 to 2285.0
|
1618.0 SFC/1x10^6 PBMC
Interval 1010.0 to 5785.0
|
|
Immunogenicity - T-cell Response
T-cell response week 4
|
788.0 SFC/1x10^6 PBMC
Interval 425.0 to 1353.0
|
1120.0 SFC/1x10^6 PBMC
Interval 368.0 to 2193.0
|
1330.0 SFC/1x10^6 PBMC
Interval 573.0 to 2285.0
|
1153.0 SFC/1x10^6 PBMC
Interval 745.0 to 2188.0
|
1258.0 SFC/1x10^6 PBMC
Interval 395.0 to 2000.0
|
1645.0 SFC/1x10^6 PBMC
Interval 1183.0 to 4215.0
|
|
Immunogenicity - T-cell Response
T-cell response week 8
|
720.0 SFC/1x10^6 PBMC
Interval 355.0 to 945.0
|
948.0 SFC/1x10^6 PBMC
Interval 329.0 to 1468.0
|
1172.0 SFC/1x10^6 PBMC
Interval 628.0 to 1570.0
|
898.0 SFC/1x10^6 PBMC
Interval 403.0 to 1273.0
|
888.0 SFC/1x10^6 PBMC
Interval 353.0 to 1920.0
|
2133.0 SFC/1x10^6 PBMC
Interval 945.0 to 3538.0
|
|
Immunogenicity - T-cell Response
T-cell response week 12
|
570.0 SFC/1x10^6 PBMC
Interval 458.0 to 733.0
|
655.0 SFC/1x10^6 PBMC
Interval 368.0 to 1073.0
|
856.0 SFC/1x10^6 PBMC
Interval 570.0 to 1553.0
|
898.0 SFC/1x10^6 PBMC
Interval 435.0 to 1670.0
|
835.0 SFC/1x10^6 PBMC
Interval 358.0 to 1278.0
|
1435.0 SFC/1x10^6 PBMC
Interval 760.0 to 2943.0
|
|
Immunogenicity - T-cell Response
T-cell response week 24
|
538.0 SFC/1x10^6 PBMC
Interval 243.0 to 693.0
|
500.0 SFC/1x10^6 PBMC
Interval 238.0 to 918.0
|
798.0 SFC/1x10^6 PBMC
Interval 220.0 to 968.0
|
740.5 SFC/1x10^6 PBMC
Interval 529.0 to 936.5
|
643.0 SFC/1x10^6 PBMC
Interval 468.0 to 823.0
|
1223.0 SFC/1x10^6 PBMC
Interval 823.0 to 1930.0
|
Adverse Events
Arm 1 - Low Dose
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
Arm 2 - Intermediate Dose
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Arm 3 - High Dose
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Arm 4 - Low Dose
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Arm 5 - Intermediate Dose
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Arm 6 - High Dose
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Arm 1 - Low Dose
n=15 participants at risk
Arm-1 Healthy adult volunteers aged 18-55y will receive IM single dose of 5e10vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 2 - Intermediate Dose
n=15 participants at risk
Arm-2 Healthy adult volunteers aged 18-55y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 3 - High Dose
n=15 participants at risk
Arm-3 Healthy adult volunteers aged 18-55y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 4 - Low Dose
n=16 participants at risk
Arm-4 Healthy elderly volunteers aged 65-85y will receive IM single dose of 5e10vp. N=16
GRAd-COV2: Single intramuscular administration.
|
Arm 5 - Intermediate Dose
n=15 participants at risk
Arm-5 Healthy elderly volunteers aged 65-85y will receive IM single dose of 1e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
Arm 6 - High Dose
n=15 participants at risk
Arm-6 Healthy elderly volunteers aged 65-85y will receive IM single dose of 2e11vp. N=15
GRAd-COV2: Single intramuscular administration.
|
|---|---|---|---|---|---|---|
|
General disorders
Injection Site hematoma
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Nervous system disorders
Headache
|
40.0%
6/15 • Number of events 11 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
53.3%
8/15 • Number of events 16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
73.3%
11/15 • Number of events 15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
43.8%
7/16 • Number of events 10 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
20.0%
3/15 • Number of events 4 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
13.3%
2/15 • Number of events 2 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
General disorders
Fatigue
|
60.0%
9/15 • Number of events 31 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
46.7%
7/15 • Number of events 35 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
66.7%
10/15 • Number of events 11 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
43.8%
7/16 • Number of events 13 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
20.0%
3/15 • Number of events 4 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
26.7%
4/15 • Number of events 4 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
General disorders
injection site pain
|
66.7%
10/15 • Number of events 11 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
80.0%
12/15 • Number of events 14 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
66.7%
10/15 • Number of events 10 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
12.5%
2/16 • Number of events 3 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
26.7%
4/15 • Number of events 4 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
General disorders
Pyrexia
|
20.0%
3/15 • Number of events 5 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
26.7%
4/15 • Number of events 6 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
73.3%
11/15 • Number of events 15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
31.2%
5/16 • Number of events 6 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
26.7%
4/15 • Number of events 11 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
26.7%
4/15 • Number of events 4 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
General disorders
Chills
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
13.3%
2/15 • Number of events 2 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
40.0%
6/15 • Number of events 6 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
25.0%
4/16 • Number of events 7 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
26.7%
4/15 • Number of events 4 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
40.0%
6/15 • Number of events 7 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
General disorders
Injection Site Erithema
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
13.3%
2/15 • Number of events 2 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
13.3%
2/15 • Number of events 2 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
General disorders
Injection Site swelling
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Nervous system disorders
Paraesthesia
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
40.0%
6/15 • Number of events 6 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
26.7%
4/15 • Number of events 4 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
37.5%
6/16 • Number of events 12 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
33.3%
5/15 • Number of events 5 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Musculoskeletal and connective tissue disorders
Neck Pain
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Musculoskeletal and connective tissue disorders
Muscle contracture
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Musculoskeletal and connective tissue disorders
Spinal Pain
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Gastrointestinal disorders
Nausea
|
13.3%
2/15 • Number of events 3 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
26.7%
4/15 • Number of events 4 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
20.0%
3/15 • Number of events 3 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.2%
1/16 • Number of events 3 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
20.0%
3/15 • Number of events 3 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
13.3%
2/15 • Number of events 2 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Gastrointestinal disorders
Diarrhoea
|
13.3%
2/15 • Number of events 2 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
26.7%
4/15 • Number of events 4 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
20.0%
3/15 • Number of events 3 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
13.3%
2/15 • Number of events 2 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Gastrointestinal disorders
Abdominal Pain
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
26.7%
4/15 • Number of events 5 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.2%
1/16 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Gastrointestinal disorders
Faeces Soft
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Blood and lymphatic system disorders
Neutropoenia
|
6.7%
1/15 • Number of events 2 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
13.3%
2/15 • Number of events 2 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.2%
1/16 • Number of events 2 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
13.3%
2/15 • Number of events 2 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Injury, poisoning and procedural complications
Muscle Strain
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Injury, poisoning and procedural complications
Tooth Fracture
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
13.3%
2/15 • Number of events 3 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
13.3%
2/15 • Number of events 2 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Infections and infestations
Conjunctivitis
|
6.7%
1/15 • Number of events 2 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Infections and infestations
Oral Herpes
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Infections and infestations
Tooth Abscess
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.2%
1/16 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Reproductive system and breast disorders
Premenstrual Syndrome
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Eye disorders
Chalazion
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Investigations
Aspartate Aminotransferase increased
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Metabolism and nutrition disorders
Hyperkaliemia
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Vascular disorders
Hot Flush
|
6.7%
1/15 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/16 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
6.2%
1/16 • Number of events 1 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
0.00%
0/15 • Adverse Event occurred during the study period from enrollment to week 24
Adverse events summarized by system organ class (SOC) and preferred term (PT), with number and percentage of subjects as well as the total number of occurrences. Adverse event summaries were ordered in terms of decreasing frequency for SOC and PT within SOC in the Total group and then alphabetically for SOC and PT within SOC. Summaries were ordered in terms of decreasing frequency for PT in the Total group in summaries where SOC was not included.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Publication of the results will be agreed between ReiThera SRL and Istituto Nazionale per le Malattie Infettive Lazzaro Spallanzani. If one of the parties is interested in proceeding with a scientific publication, it must give written and electronic communication to the other party. Any impediments to publication must be communicated electronically within 30 days. If a party deems it inappropriate to publish, it will try to provide written changes to the text that could allow its publication.
- Publication restrictions are in place
Restriction type: OTHER