Trial Outcomes & Findings for First-in-Human, Phase 1b/2a Trial of a Multipeptide Therapeutic Vaccine in Patients With Progressive Glioblastoma (NCT NCT04116658)
NCT ID: NCT04116658
Last Updated: 2025-11-28
Results Overview
Incidences of treatment-emergent Serious Adverse Events ( SAEs) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
100 participants
Primary outcome timeframe
From treatment start up to study end, assessed up to 27.5 months
Results posted on
2025-11-28
Participant Flow
Participant milestones
| Measure |
Cohort 1
EO2041 (1,2 mg) monotherapy followed by continued EO2401 in combination with nivolumab
|
Cohort 2
EO2041 (1,2mg) in combination with nivolumab
|
Cohort 3
EO2041 (1,2mg) in combination with nivolumab and bevacizumab
|
|---|---|---|---|
|
Overall Study
STARTED
|
21
|
53
|
26
|
|
Overall Study
COMPLETED
|
21
|
53
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
First-in-Human, Phase 1b/2a Trial of a Multipeptide Therapeutic Vaccine in Patients With Progressive Glioblastoma
Baseline characteristics by cohort
| Measure |
Cohort 1
n=21 Participants
EO2041 monotherapy followed by continued EO2401 in combination with nivolumab
|
Cohort 2
n=53 Participants
EO2041 in combination with nivolumab
|
Cohort 3
n=26 Participants
EO2041 in combination with nivolumab and bevacizumab
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
58 years
n=9 Participants
|
57 years
n=6 Participants
|
60.5 years
n=9 Participants
|
58 years
n=78 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=9 Participants
|
21 Participants
n=6 Participants
|
10 Participants
n=9 Participants
|
38 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=9 Participants
|
32 Participants
n=6 Participants
|
16 Participants
n=9 Participants
|
62 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
2 Participants
n=6 Participants
|
2 Participants
n=9 Participants
|
4 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
19 Participants
n=9 Participants
|
46 Participants
n=6 Participants
|
24 Participants
n=9 Participants
|
89 Participants
n=78 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=9 Participants
|
5 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
7 Participants
n=78 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
1 Participants
n=9 Participants
|
2 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
1 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=9 Participants
|
4 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
4 Participants
n=78 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=9 Participants
|
48 Participants
n=6 Participants
|
25 Participants
n=9 Participants
|
92 Participants
n=78 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
0 Participants
n=78 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=9 Participants
|
0 Participants
n=6 Participants
|
0 Participants
n=9 Participants
|
1 Participants
n=78 Participants
|
PRIMARY outcome
Timeframe: From treatment start up to study end, assessed up to 27.5 monthsIncidences of treatment-emergent Serious Adverse Events ( SAEs) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Outcome measures
| Measure |
Cohort 1
n=21 Participants
EO2041 monotherapy followed by continued EO2401 in combination with nivolumab
|
Cohort 2
n=53 Participants
EO2041 in combination with nivolumab
|
Cohort 3
n=26 Participants
EO2041 in combination with nivolumab and bevacizumab
|
|---|---|---|---|
|
Safety and Tolerability of EO2401 Monotherapy, EO2401 in Combination With Nivolumab , EO2401 in Combination With Nivolumab and Bevacizumab
|
9 Participants
|
8 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: From treatment start up to study end, assessed up to 27.5 monthsIncidences of treatment-emergent AEs (TEAEs) using the National Cancer Institute-Common Terminology Criteria for AEs (NCI-CTCAE) v5.0.
Outcome measures
| Measure |
Cohort 1
n=21 Participants
EO2041 monotherapy followed by continued EO2401 in combination with nivolumab
|
Cohort 2
n=53 Participants
EO2041 in combination with nivolumab
|
Cohort 3
n=26 Participants
EO2041 in combination with nivolumab and bevacizumab
|
|---|---|---|---|
|
Safety and Tolerability of EO2401 Monotherapy, EO2401 in Combination With Nivolumab , EO2401 in Combination With Nivolumab and Bevacizumab
|
21 Participants
|
51 Participants
|
26 Participants
|
PRIMARY outcome
Timeframe: From treatment start up to study end, assessed up to 44 monthsIncidences of deaths
Outcome measures
| Measure |
Cohort 1
n=21 Participants
EO2041 monotherapy followed by continued EO2401 in combination with nivolumab
|
Cohort 2
n=53 Participants
EO2041 in combination with nivolumab
|
Cohort 3
n=26 Participants
EO2041 in combination with nivolumab and bevacizumab
|
|---|---|---|---|
|
Safety and Tolerability of EO2401 Monotherapy, EO2401 in Combination With Nivolumab , EO2401 in Combination With Nivolumab and Bevacizumab
|
20 Participants
|
46 Participants
|
23 Participants
|
SECONDARY outcome
Timeframe: From treatment start up to study end, assessed up to 44 monthsOverall survival, defined as the time interval from the date of first study treatment administration to the date of death due to any cause
Outcome measures
| Measure |
Cohort 1
n=21 Participants
EO2041 monotherapy followed by continued EO2401 in combination with nivolumab
|
Cohort 2
n=53 Participants
EO2041 in combination with nivolumab
|
Cohort 3
n=26 Participants
EO2041 in combination with nivolumab and bevacizumab
|
|---|---|---|---|
|
Evaluation of Survival
|
9.6 months
Interval 5.9 to 10.8
|
11.3 months
Interval 9.0 to 13.7
|
12.1 months
Interval 8.0 to 14.8
|
SECONDARY outcome
Timeframe: 6 weeks after treatment startAt least one positive response (proof of CD8 T cells specific for the EO2401 mimic peptides and/or for the tumor associated antigen (TAA) target peptides) in either of the used immunomonitoring assays (i.e. CD8 T cell expansion in peripheral blood measured by tetramers/flow cytometry, and Spot-Forming Cells by IFN-γ ELISPOT, both methods applied ex vivo, i.e. without prolonged in vitro stimulation and after in vitro stimulation)
Outcome measures
| Measure |
Cohort 1
n=18 Participants
EO2041 monotherapy followed by continued EO2401 in combination with nivolumab
|
Cohort 2
n=30 Participants
EO2041 in combination with nivolumab
|
Cohort 3
n=22 Participants
EO2041 in combination with nivolumab and bevacizumab
|
|---|---|---|---|
|
Assessment of the Immunogenicity of EO2316, EO2317, EO2318 (Three Components of the Therapeutic Vaccine), and Universal Cancer Peptide That Compose EO2401
|
17 Participants
|
29 Participants
|
20 Participants
|
Adverse Events
Cohort 1
Serious events: 9 serious events
Other events: 20 other events
Deaths: 20 deaths
Cohort 2
Serious events: 8 serious events
Other events: 51 other events
Deaths: 46 deaths
Cohort 3
Serious events: 8 serious events
Other events: 26 other events
Deaths: 23 deaths
Serious adverse events
| Measure |
Cohort 1
n=21 participants at risk
EO2041 monotherapy followed by continued EO2401 in combination with nivolumab
|
Cohort 2
n=53 participants at risk
EO2401 in combination with nivolumab
|
Cohort 3
n=26 participants at risk
EO2401 in combination with nivolumab and bevacizumab
|
|---|---|---|---|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
General disorders
Chills
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
General disorders
Condition aggravated
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
General physical health deterioration
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Pyrexia
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
Meningitis aseptic
|
9.5%
2/21 • Number of events 2 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 3 • 44 months
|
0.00%
0/26 • 44 months
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Injury, poisoning and procedural complications
Radius fracture
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Immune-mediated arthritis
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Brain oedema
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Cerebrovascular accident
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Epilepsy
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Nervous system disorders
Headache
|
0.00%
0/21 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Motor dysfunction
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Neurological decompensation
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Seizure
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Nervous system disorders
Status epilepticus
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
Other adverse events
| Measure |
Cohort 1
n=21 participants at risk
EO2041 monotherapy followed by continued EO2401 in combination with nivolumab
|
Cohort 2
n=53 participants at risk
EO2401 in combination with nivolumab
|
Cohort 3
n=26 participants at risk
EO2401 in combination with nivolumab and bevacizumab
|
|---|---|---|---|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/21 • 44 months
|
5.7%
3/53 • Number of events 5 • 44 months
|
23.1%
6/26 • Number of events 10 • 44 months
|
|
Metabolism and nutrition disorders
Hypernatraemia
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
11.5%
3/26 • Number of events 3 • 44 months
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/21 • 44 months
|
3.8%
2/53 • Number of events 4 • 44 months
|
15.4%
4/26 • Number of events 10 • 44 months
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
4.8%
1/21 • Number of events 1 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
15.4%
4/26 • Number of events 5 • 44 months
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
7.7%
2/26 • Number of events 4 • 44 months
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
15.4%
4/26 • Number of events 8 • 44 months
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/21 • 44 months
|
3.8%
2/53 • Number of events 4 • 44 months
|
19.2%
5/26 • Number of events 5 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 3 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.5%
2/21 • Number of events 3 • 44 months
|
5.7%
3/53 • Number of events 3 • 44 months
|
11.5%
3/26 • Number of events 3 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Mobility decreased
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.8%
1/21 • Number of events 1 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
7.7%
2/26 • Number of events 2 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/21 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
11.5%
3/26 • Number of events 3 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/21 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
11.5%
3/26 • Number of events 3 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/21 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
0.00%
0/26 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.8%
1/21 • Number of events 1 • 44 months
|
5.7%
3/53 • Number of events 4 • 44 months
|
0.00%
0/26 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Plantar fasciitis
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Musculoskeletal and connective tissue disorders
Torticollis
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Alexia
|
4.8%
1/21 • Number of events 2 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Amnesia
|
4.8%
1/21 • Number of events 1 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Aphasia
|
14.3%
3/21 • Number of events 5 • 44 months
|
17.0%
9/53 • Number of events 14 • 44 months
|
15.4%
4/26 • Number of events 4 • 44 months
|
|
Nervous system disorders
Apraxia
|
9.5%
2/21 • Number of events 3 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Ataxia
|
4.8%
1/21 • Number of events 1 • 44 months
|
1.9%
1/53 • Number of events 2 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Nervous system disorders
Brain injury
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Brain oedema
|
14.3%
3/21 • Number of events 3 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Clumsiness
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Cognitive disorder
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Nervous system disorders
Dizziness
|
0.00%
0/21 • 44 months
|
7.5%
4/53 • Number of events 7 • 44 months
|
19.2%
5/26 • Number of events 5 • 44 months
|
|
Nervous system disorders
Dysdiadochokinesis
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 2 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Dysgeusia
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Epilepsy
|
9.5%
2/21 • Number of events 2 • 44 months
|
1.9%
1/53 • Number of events 2 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Nervous system disorders
Facial paresis
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Fine motor skill dysfunction
|
4.8%
1/21 • Number of events 2 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Nervous system disorders
Headache
|
9.5%
2/21 • Number of events 4 • 44 months
|
34.0%
18/53 • Number of events 32 • 44 months
|
34.6%
9/26 • Number of events 14 • 44 months
|
|
Nervous system disorders
Hemianopia
|
4.8%
1/21 • Number of events 1 • 44 months
|
7.5%
4/53 • Number of events 4 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Hemihypoaesthesia
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Hemiparesis
|
28.6%
6/21 • Number of events 7 • 44 months
|
11.3%
6/53 • Number of events 7 • 44 months
|
19.2%
5/26 • Number of events 10 • 44 months
|
|
Nervous system disorders
Hypoaesthesia
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Language disorder
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Memory impairment
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
15.4%
4/26 • Number of events 4 • 44 months
|
|
Nervous system disorders
Monoparesis
|
4.8%
1/21 • Number of events 2 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Neurological decompensation
|
4.8%
1/21 • Number of events 1 • 44 months
|
5.7%
3/53 • Number of events 3 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/21 • 44 months
|
9.4%
5/53 • Number of events 5 • 44 months
|
11.5%
3/26 • Number of events 5 • 44 months
|
|
Nervous system disorders
Partial seizures
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
7.7%
2/26 • Number of events 6 • 44 months
|
|
Nervous system disorders
Pyramidal tract syndrome
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Quadrantanopia
|
0.00%
0/21 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
0.00%
0/26 • 44 months
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Nervous system disorders
Seizure
|
9.5%
2/21 • Number of events 3 • 44 months
|
5.7%
3/53 • Number of events 4 • 44 months
|
26.9%
7/26 • Number of events 19 • 44 months
|
|
Nervous system disorders
Somnolence
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Nervous system disorders
Tremor
|
0.00%
0/21 • 44 months
|
3.8%
2/53 • Number of events 3 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Nervous system disorders
Vibratory sense increased
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Psychiatric disorders
Affect lability
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Psychiatric disorders
Agitation
|
4.8%
1/21 • Number of events 2 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Psychiatric disorders
Anxiety
|
4.8%
1/21 • Number of events 1 • 44 months
|
7.5%
4/53 • Number of events 4 • 44 months
|
7.7%
2/26 • Number of events 2 • 44 months
|
|
Psychiatric disorders
Bradyphrenia
|
0.00%
0/21 • 44 months
|
3.8%
2/53 • Number of events 6 • 44 months
|
0.00%
0/26 • 44 months
|
|
Psychiatric disorders
Confusional state
|
4.8%
1/21 • Number of events 2 • 44 months
|
1.9%
1/53 • Number of events 3 • 44 months
|
15.4%
4/26 • Number of events 6 • 44 months
|
|
Psychiatric disorders
Depression
|
0.00%
0/21 • 44 months
|
5.7%
3/53 • Number of events 3 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 6 • 44 months
|
0.00%
0/26 • 44 months
|
|
Psychiatric disorders
Insomnia
|
4.8%
1/21 • Number of events 1 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
15.4%
4/26 • Number of events 4 • 44 months
|
|
Psychiatric disorders
Learning disorder
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Psychiatric disorders
Mutism
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
23.1%
6/26 • Number of events 13 • 44 months
|
|
Renal and urinary disorders
Urinary incontinence
|
4.8%
1/21 • Number of events 1 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
7.7%
2/26 • Number of events 2 • 44 months
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Aphonia
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
2/21 • Number of events 2 • 44 months
|
0.00%
0/53 • 44 months
|
15.4%
4/26 • Number of events 5 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
4.8%
1/21 • Number of events 1 • 44 months
|
7.5%
4/53 • Number of events 4 • 44 months
|
0.00%
0/26 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
11.5%
3/26 • Number of events 3 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
7.7%
2/26 • Number of events 2 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Skin and subcutaneous tissue disorders
Cellulite
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/21 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
0.00%
0/26 • 44 months
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/21 • 44 months
|
7.5%
4/53 • Number of events 4 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Skin and subcutaneous tissue disorders
Immune-mediated dermatitis
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Skin and subcutaneous tissue disorders
Penile ulceration
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/21 • 44 months
|
9.4%
5/53 • Number of events 5 • 44 months
|
7.7%
2/26 • Number of events 2 • 44 months
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/21 • 44 months
|
5.7%
3/53 • Number of events 3 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
9.5%
2/21 • Number of events 3 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Skin and subcutaneous tissue disorders
Toxic skin eruption
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 2 • 44 months
|
|
Skin and subcutaneous tissue disorders
Vitiligo
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Vascular disorders
Haematoma
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Vascular disorders
Hypertension
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 2 • 44 months
|
19.2%
5/26 • Number of events 6 • 44 months
|
|
Vascular disorders
Hypotension
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 3 • 44 months
|
0.00%
0/26 • 44 months
|
|
Infections and infestations
Coronavirus infection
|
14.3%
3/21 • Number of events 3 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
Cystitis
|
0.00%
0/21 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
0.00%
0/26 • 44 months
|
|
Infections and infestations
Diverticulitis
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Infections and infestations
Folliculitis
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Infections and infestations
Fungal skin infection
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
Genital infection fungal
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
Gingivitis
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Infections and infestations
Injection site infection
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
Paronychia
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Infections and infestations
Periodontitis
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
Pneumonia
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
Pustule
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
Respiratory tract infection
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
Rhinitis
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
Scrotal infection
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
7.7%
2/26 • Number of events 2 • 44 months
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
Urinary tract infection
|
4.8%
1/21 • Number of events 1 • 44 months
|
1.9%
1/53 • Number of events 2 • 44 months
|
7.7%
2/26 • Number of events 3 • 44 months
|
|
Infections and infestations
Wound infection
|
0.00%
0/21 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
0.00%
0/26 • 44 months
|
|
Injury, poisoning and procedural complications
Bone fissure
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Injury, poisoning and procedural complications
Fall
|
14.3%
3/21 • Number of events 3 • 44 months
|
7.5%
4/53 • Number of events 6 • 44 months
|
23.1%
6/26 • Number of events 9 • 44 months
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Injury, poisoning and procedural complications
Vaccination complication
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Investigations
Alanine aminotransferase increased
|
19.0%
4/21 • Number of events 4 • 44 months
|
13.2%
7/53 • Number of events 8 • 44 months
|
26.9%
7/26 • Number of events 12 • 44 months
|
|
Investigations
Aspartate aminotransferase increased
|
14.3%
3/21 • Number of events 4 • 44 months
|
7.5%
4/53 • Number of events 4 • 44 months
|
30.8%
8/26 • Number of events 11 • 44 months
|
|
Investigations
Blood alkaline phosphatase increased
|
4.8%
1/21 • Number of events 1 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
11.5%
3/26 • Number of events 6 • 44 months
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/21 • 44 months
|
3.8%
2/53 • Number of events 3 • 44 months
|
7.7%
2/26 • Number of events 3 • 44 months
|
|
Investigations
Blood cholesterol increased
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Investigations
Blood creatinine increased
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Investigations
Blood pressure increased
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Investigations
Blood thyroid stimulating hormone decreased
|
4.8%
1/21 • Number of events 1 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
0.00%
0/26 • 44 months
|
|
Investigations
Blood thyroid stimulating hormone increased
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
23.1%
6/26 • Number of events 6 • 44 months
|
|
Investigations
Blood urea increased
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Investigations
C-reactive protein increased
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Investigations
Gamma-glutamyltransferase increased
|
23.8%
5/21 • Number of events 6 • 44 months
|
5.7%
3/53 • Number of events 3 • 44 months
|
11.5%
3/26 • Number of events 9 • 44 months
|
|
Investigations
Lymphocyte count decreased
|
9.5%
2/21 • Number of events 6 • 44 months
|
13.2%
7/53 • Number of events 17 • 44 months
|
38.5%
10/26 • Number of events 29 • 44 months
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/21 • 44 months
|
5.7%
3/53 • Number of events 5 • 44 months
|
15.4%
4/26 • Number of events 6 • 44 months
|
|
Investigations
Platelet count decreased
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
19.2%
5/26 • Number of events 8 • 44 months
|
|
Investigations
SARS-CoV-2 test positive
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Investigations
Thyroxine decreased
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Investigations
Thyroxine increased
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Investigations
Troponin T increased
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Investigations
Troponin increased
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
7.7%
2/26 • Number of events 2 • 44 months
|
|
Investigations
Weight decreased
|
0.00%
0/21 • 44 months
|
5.7%
3/53 • Number of events 3 • 44 months
|
0.00%
0/26 • 44 months
|
|
Investigations
White blood cell count decreased
|
0.00%
0/21 • 44 months
|
5.7%
3/53 • Number of events 5 • 44 months
|
19.2%
5/26 • Number of events 6 • 44 months
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/21 • 44 months
|
7.5%
4/53 • Number of events 4 • 44 months
|
7.7%
2/26 • Number of events 2 • 44 months
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
General disorders
Chills
|
0.00%
0/21 • 44 months
|
5.7%
3/53 • Number of events 3 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
General disorders
Disease progression
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Face oedema
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Fatigue
|
23.8%
5/21 • Number of events 5 • 44 months
|
28.3%
15/53 • Number of events 19 • 44 months
|
30.8%
8/26 • Number of events 9 • 44 months
|
|
General disorders
Gait disturbance
|
0.00%
0/21 • 44 months
|
3.8%
2/53 • Number of events 3 • 44 months
|
19.2%
5/26 • Number of events 7 • 44 months
|
|
Infections and infestations
Cellulitis
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
General physical health deterioration
|
19.0%
4/21 • Number of events 4 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Influenza like illness
|
0.00%
0/21 • 44 months
|
5.7%
3/53 • Number of events 4 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Injection site discharge
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Injection site discomfort
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Injection site erythema
|
4.8%
1/21 • Number of events 2 • 44 months
|
9.4%
5/53 • Number of events 10 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
General disorders
Injection site granuloma
|
14.3%
3/21 • Number of events 3 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Injection site haematoma
|
4.8%
1/21 • Number of events 2 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Injection site induration
|
0.00%
0/21 • 44 months
|
11.3%
6/53 • Number of events 8 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Injection site inflammation
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Injection site nodule
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Injection site pain
|
0.00%
0/21 • 44 months
|
5.7%
3/53 • Number of events 5 • 44 months
|
7.7%
2/26 • Number of events 2 • 44 months
|
|
General disorders
Injection site pruritus
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Injection site reaction
|
23.8%
5/21 • Number of events 9 • 44 months
|
18.9%
10/53 • Number of events 25 • 44 months
|
50.0%
13/26 • Number of events 32 • 44 months
|
|
General disorders
Injection site swelling
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Local reaction
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
General disorders
Localised oedema
|
4.8%
1/21 • Number of events 1 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Medical device site fistula
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Mucosal inflammation
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
General disorders
Oedema peripheral
|
9.5%
2/21 • Number of events 2 • 44 months
|
1.9%
1/53 • Number of events 2 • 44 months
|
7.7%
2/26 • Number of events 2 • 44 months
|
|
General disorders
Pain
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
General disorders
Pyrexia
|
4.8%
1/21 • Number of events 2 • 44 months
|
11.3%
6/53 • Number of events 10 • 44 months
|
19.2%
5/26 • Number of events 6 • 44 months
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 3 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
Acne pustular
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Infections and infestations
COVID-19
|
9.5%
2/21 • Number of events 2 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Eye disorders
Blepharitis
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Eye disorders
Conjunctival haemorrhage
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 2 • 44 months
|
0.00%
0/26 • 44 months
|
|
Eye disorders
Diplopia
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Eye disorders
Eye haematoma
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Eye disorders
Eyelid ptosis
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Eye disorders
Vision blurred
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Eye disorders
Visual field defect
|
4.8%
1/21 • Number of events 1 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Eye disorders
Visual impairment
|
0.00%
0/21 • 44 months
|
3.8%
2/53 • Number of events 3 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
7.7%
2/26 • Number of events 2 • 44 months
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.8%
1/21 • Number of events 1 • 44 months
|
3.8%
2/53 • Number of events 2 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Gastrointestinal disorders
Anal erythema
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Gastrointestinal disorders
Anal incontinence
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Gastrointestinal disorders
Angular cheilitis
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/21 • 44 months
|
9.4%
5/53 • Number of events 5 • 44 months
|
15.4%
4/26 • Number of events 5 • 44 months
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Gastrointestinal disorders
Diarrhoea
|
4.8%
1/21 • Number of events 1 • 44 months
|
3.8%
2/53 • Number of events 3 • 44 months
|
15.4%
4/26 • Number of events 6 • 44 months
|
|
Gastrointestinal disorders
Dry mouth
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Gastrointestinal disorders
Faeces discoloured
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Gastrointestinal disorders
Gingival pain
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Gastrointestinal disorders
Intestinal mass
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Gastrointestinal disorders
Nausea
|
9.5%
2/21 • Number of events 2 • 44 months
|
11.3%
6/53 • Number of events 7 • 44 months
|
15.4%
4/26 • Number of events 6 • 44 months
|
|
Gastrointestinal disorders
Stomatitis
|
4.8%
1/21 • Number of events 1 • 44 months
|
0.00%
0/53 • 44 months
|
0.00%
0/26 • 44 months
|
|
Gastrointestinal disorders
Vomiting
|
14.3%
3/21 • Number of events 3 • 44 months
|
7.5%
4/53 • Number of events 5 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
General disorders
Asthenia
|
9.5%
2/21 • Number of events 3 • 44 months
|
11.3%
6/53 • Number of events 13 • 44 months
|
0.00%
0/26 • 44 months
|
|
General disorders
Chest pain
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Blood and lymphatic system disorders
Anaemia
|
4.8%
1/21 • Number of events 1 • 44 months
|
7.5%
4/53 • Number of events 6 • 44 months
|
15.4%
4/26 • Number of events 5 • 44 months
|
|
Blood and lymphatic system disorders
Lymphopenia
|
4.8%
1/21 • Number of events 1 • 44 months
|
5.7%
3/53 • Number of events 3 • 44 months
|
0.00%
0/26 • 44 months
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
9.5%
2/21 • Number of events 2 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Cardiac disorders
Conduction disorder
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
0.00%
0/26 • 44 months
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/21 • 44 months
|
1.9%
1/53 • Number of events 1 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Endocrine disorders
Adrenal insufficiency
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
23.1%
6/26 • Number of events 9 • 44 months
|
|
Endocrine disorders
Androgen deficiency
|
0.00%
0/21 • 44 months
|
0.00%
0/53 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
|
Endocrine disorders
Hyperthyroidism
|
4.8%
1/21 • Number of events 1 • 44 months
|
5.7%
3/53 • Number of events 3 • 44 months
|
7.7%
2/26 • Number of events 2 • 44 months
|
|
Endocrine disorders
Hypothyroidism
|
14.3%
3/21 • Number of events 3 • 44 months
|
5.7%
3/53 • Number of events 3 • 44 months
|
3.8%
1/26 • Number of events 1 • 44 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER