Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of specific, pre-defined adverse events.
The pre-defined events include: injection site reaction, flu like syndrome, fatigue, gastro-intestinal signs, allergic signs.
Presence/absence of abnormal vital signs
(based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)
Presence/absence of abnormal vital signs
(based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)
Presence/absence of abnormal vital signs
(based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)
Presence/absence of abnormal vital signs
(based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)
Presence/absence of abnormal vital signs
(based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)
Presence/absence of abnormal vital signs
(based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)
Presence/absence of abnormal vital signs
(based on a systematic check of vital signs: pulse, blood pressure, oxymetry, temperature)
MedDRA classification of all adverse events throughout the study
MedDRA refers to "Medical Dictionary for Regulatory Activities"
Thyroid function: blood T4
Thyroid function: blood T4
Thyroid function: blood TSH
Thyroid function: blood TSH
Presence/absence of clinically significant abnormality on a lung x-ray
Presence/absence of clinically significant abnormality on a lung x-ray
Presence/absence of clinically significant abnormality on an electrocardiogram
Presence/absence of clinically significant abnormality on an electrocardiogram
Presence/absence of a clinically significant abnormality among routine laboratory tests
The routine blood tests considered are:
haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration )
blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)
liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)
iron metabolism (iron, ferritin, transferrin)
Presence/absence of a clinically significant abnormality among routine laboratory tests
The routine blood tests considered are:
haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)
blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)
liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)
iron metabolism (iron, ferritin, transferrin)
Presence/absence of a clinically significant abnormality among routine laboratory tests
The routine blood tests considered are:
haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)
blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)
liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)
iron metabolism (iron, ferritin, transferrin)
Presence/absence of a clinically significant abnormality among routine laboratory tests
The routine blood tests considered are:
haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)
blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)
liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)
iron metabolism (iron, ferritin, transferrin)
Presence/absence of a clinically significant abnormality among routine laboratory tests
The routine blood tests considered are:
haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)
blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)
liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)
iron metabolism (iron, ferritin, transferrin)
Presence/absence of a clinically significant abnormality among routine laboratory tests
The routine blood tests considered are:
haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)
blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)
liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)
iron metabolism (iron, ferritin, transferrin)
Presence/absence of a clinically significant abnormality among routine laboratory tests
The routine blood tests considered are:
haemogram (hemoglobin, hematocrit, red blood cell count, white blood cell count, leukocyte formula, platelets, mean corpuscular volume, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration)
blood biochemistry (ionogram, urea, creatinine, glucose, C reactive protein, procalcitonin, protein, albumin)
liver function panel (aspartate transaminase, alanine transaminase, gamma-glutamyl transpeptidase, bilirubin)
iron metabolism (iron, ferritin, transferrin)
Vital capacity (% of normal)
This is a measure of respiratory function.
Vital capacity (% of normal)
This is a measure of respiratory function.
Vital capacity (% of normal)
This is a measure of respiratory function.
Vital capacity (% of normal)
This is a measure of respiratory function.
Tregs (absolute number and % CF4+ cells)
Tregs (absolute number and % CF4+ cells)
Tregs (absolute number and % CF4+ cells)
Tregs (absolute number and % CF4+ cells)
Tregs (absolute number and % CF4+ cells)
Tregs (absolute number and % CF4+ cells)
CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes
CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes
CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes
CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes
CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes
CD56+(NK), CD19+(B), CD3+, CD4+, CD8+ cell populations: numbers and percentages of total lymphocytes
effector T cells: number and % of CD4 cells
This is measured as CD4+ lymphocytes minus regulatory T cells
effector T cells: number and % of CD4 cells
This is measured as CD4+ lymphocytes minus regulatory T cells
effector T cells: number and % of CD4 cells
This is measured as CD4+ lymphocytes minus regulatory T cells
effector T cells: number and % of CD4 cells
This is measured as CD4+ lymphocytes minus regulatory T cells
effector T cells: number and % of CD4 cells
This is measured as CD4+ lymphocytes minus regulatory T cells
effector T cells: number and % of CD4 cells
This is measured as CD4+ lymphocytes minus regulatory T cells
Phosphorylated neurofilament heavy protein (pNfH) levels in serum
Light chain neurofilament levels in serum
Light chain neurofilament levels in serum