Trial Outcomes & Findings for Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease (NCT NCT01369225)
NCT ID: NCT01369225
Last Updated: 2017-03-10
Results Overview
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
52 participants
Primary outcome timeframe
Baseline up to Week 52
Results posted on
2017-03-10
Participant Flow
This study enrolled participants who completed the first-in-human (FIH) study, B2601001.
Participant milestones
| Measure |
AAB-003 0.5 mg/kg
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 1 mg/kg
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
3
|
12
|
10
|
12
|
9
|
|
Overall Study
COMPLETED
|
4
|
3
|
9
|
8
|
10
|
9
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
3
|
2
|
2
|
0
|
Reasons for withdrawal
| Measure |
AAB-003 0.5 mg/kg
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 1 mg/kg
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
2
|
1
|
0
|
0
|
|
Overall Study
Does Not Meet Entrance Criteria
|
0
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Other
|
1
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
0
|
0
|
1
|
1
|
0
|
Baseline Characteristics
Open Label Extension Study Evaluating Safety and Tolerability of AAB-003 (PF-05236812) in Subject With Mild to Moderate Alzheimer's Disease
Baseline characteristics by cohort
| Measure |
AAB-003 0.5 mg/kg
n=6 Participants
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 1 mg/kg
n=3 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 Participants
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Total
n=52 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
65.2 years
STANDARD_DEVIATION 6.5 • n=5 Participants
|
63.0 years
STANDARD_DEVIATION 7.8 • n=7 Participants
|
68.8 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
71.3 years
STANDARD_DEVIATION 8.8 • n=4 Participants
|
60.7 years
STANDARD_DEVIATION 5.8 • n=21 Participants
|
71.7 years
STANDARD_DEVIATION 7.9 • n=10 Participants
|
67.1 years
STANDARD_DEVIATION 9.0 • n=115 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
33 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
5 Participants
n=10 Participants
|
19 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).
An AE was any untoward medical occurrence in a participant who received study drug. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Treatment-emergent are events between first dose of study drug and up to 28 days after last dose that were absent before treatment or that worsened relative to pre-treatment state. AEs included both SAEs and non-SAEs.
Outcome measures
| Measure |
AAB-003 1 mg/kg
n=3 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 Participants
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 0.5 mg/kg
n=6 Participants
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants with AEs
|
3 participants
|
9 participants
|
5 participants
|
10 participants
|
8 participants
|
5 participants
|
|
Number of Participants With Treatment-Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of Participants with SAEs
|
1 participants
|
2 participants
|
3 participants
|
1 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).
The following laboratory parameters were analyzed: hematology (hemoglobin, hematocrit, red blood cell \[RBC\] count, RBC morphology, platelet count, white blood cell \[WBC\] count, total neutrophils, eosinophils, monocytes, basophils, lymphocytes); blood chemistry (blood urea nitrogen \[BUN\], creatinine, glucose, calcium, sodium, potassium, chloride, total bicarbonate, aspartate aminotransferase \[AST\], alanine aminotransferase \[ALT\], total bilirubin, alkaline phosphatase, uric acid, albumin, and total protein; urinalysis (pH, glucose, protein, blood, ketones, nitrites, leukocyte esterase, microscopy \[if urine dipstick was positive for blood, protein, nitrites or leukocyte esterase\]); others (coagulation panel, circulating immune complex, and complement activation).
Outcome measures
| Measure |
AAB-003 1 mg/kg
n=3 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 Participants
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 0.5 mg/kg
n=6 Participants
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Laboratory Abnormalities Meeting the Criteria for Potential Clinical Concern
|
2 participants
|
8 participants
|
7 participants
|
10 participants
|
6 participants
|
3 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).
Vital signs assessment included pulse rate and blood pressure. Criteria for vital sign values meeting potential clinical concern included: supine/sitting pulse rate \<40 or \>120 beats per minute (bpm); standing pulse rate \<40 or \>140 bpm; systolic blood pressure (SBP) of more than or equal to (\>=)30 millimeters of mercury (mm Hg) change from baseline in same posture or SBP \<90 mm Hg, diastolic blood pressure (DBP) \>=20 mmHg change from baseline in same posture or DBP \<50 mm Hg.
Outcome measures
| Measure |
AAB-003 1 mg/kg
n=3 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 Participants
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 0.5 mg/kg
n=6 Participants
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Important Vital Sign Findings
Supine DBP >=20 mm Hg Decrease from Baseline
|
1 participants
|
5 participants
|
3 participants
|
3 participants
|
5 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Important Vital Sign Findings
Supine SBP <90 mm Hg
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
|
Number of Participants With Potentially Clinically Important Vital Sign Findings
Supine DBP <50 mm Hg
|
0 participants
|
1 participants
|
3 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Important Vital Sign Findings
Supine Pulse Rate <40 or >120 bpm
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Important Vital Sign Findings
Supine SBP >=30 mm Hg Increase from Baseline
|
1 participants
|
1 participants
|
2 participants
|
4 participants
|
1 participants
|
3 participants
|
|
Number of Participants With Potentially Clinically Important Vital Sign Findings
Supine DBP >=20 mm Hg Increase from Baseline
|
1 participants
|
4 participants
|
5 participants
|
1 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Potentially Clinically Important Vital Sign Findings
Supine SBP >=30 mm Hg Decrease from Baseline
|
1 participants
|
4 participants
|
1 participants
|
2 participants
|
4 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).
ECG parameters included PR interval, QRS interval, and QT interval. Criteria for ECG changes meeting potential clinical concern included: PR interval \>=300 milliseconds (msec) or \>=25% increase when baseline is \>200 msec and \>=50% increase when baseline is less than or equal to (\<=)200 msec; QRS interval \>=200 msec or \>=50% increase from baseline when baseline is less than or equal to 100 msec and \>=25% increase when baseline is \>100 msec; and QTcF \>=450 msec or \>=30 msec increase.
Outcome measures
| Measure |
AAB-003 1 mg/kg
n=3 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 Participants
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 0.5 mg/kg
n=6 Participants
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings
PR Interval >=300 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings
QRS Complex >=200 msec
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings
QTcF Interval 450 to <480 msec
|
2 participants
|
4 participants
|
3 participants
|
2 participants
|
2 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings
QTcF Interval 480 to <500 msec
|
0 participants
|
1 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings
QTcF Interval >=500 msec
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings
PR Interval >=25/50% Increase from Baseline
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings
QRS Complex >=25/50% Increase from Baseline
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings
QTcF Interval >=30/<60 msec Change from Baseline
|
1 participants
|
4 participants
|
4 participants
|
1 participants
|
2 participants
|
2 participants
|
|
Number of Participants With Potentially Clinically Important Electrocardiogram (ECG) Findings
QTcF Interval >=60 msec Change from Baseline
|
0 participants
|
1 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).
A full physical examination consisted of an examination of the abdomen, genitourinary and cardiovascular systems, lungs, lymph nodes, mouth, musculoskeletal and neurological systems, skin, extremities, head, ears, eyes, nose, throat and thyroid gland. Criteria for abnormal physical findings was based on the investigator's discretion and any new physical examination findings were documented as AEs. Only sites with at least 1 participant abnormality are reported.
Outcome measures
| Measure |
AAB-003 1 mg/kg
n=3 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 Participants
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 0.5 mg/kg
n=6 Participants
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Physical Examination Findings
Abdomen
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Ears
|
0 participants
|
0 participants
|
2 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Extremities
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Eyes
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
General
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Lymph Nodes
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Musculoskeletal
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Nose
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Skin
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Physical Examination Findings
Thyroid
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).
Neurological examinations were done to the extent needed to assess the subject for any potential changes in neurological status, as determined by the investigator. Examinations included level of consciousness, speech, cranial nerves, motor, sensory, coordination, gait, and tendon reflexes. Only tests with at least 1 participant abnormality are reported.
Outcome measures
| Measure |
AAB-003 1 mg/kg
n=3 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 Participants
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 0.5 mg/kg
n=6 Participants
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Neurological Examination Findings
Cranial Nerve Function
|
0 participants
|
0 participants
|
2 participants
|
0 participants
|
0 participants
|
1 participants
|
|
Number of Participants With Abnormal Neurological Examination Findings
Coordination
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Neurological Examination Findings
Deep Tendon Reflexes
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Abnormal Neurological Examination Findings
Motor Function
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
|
Number of Participants With Abnormal Neurological Examination Findings
Gait and Station
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).
The C-SSRS captures the occurrence, severity, and frequency of suicide-related thoughts and behaviors during the assessment period. C-SSRS assesses whether participant experienced the following: completed suicide; suicide attempt; preparatory acts towards imminent suicidal behavior; suicidal ideation; self-injurious behavior, no suicidal intent. The results presented are the number of participants with completed suicide or non-fatal suicide events or behaviors. Worsening of suicidal ideation was an increase in severity of suicidal ideation from baseline.
Outcome measures
| Measure |
AAB-003 1 mg/kg
n=3 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 Participants
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 0.5 mg/kg
n=6 Participants
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Completed Suicide
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicide Attempt
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Imminent Suicidal Behavior
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Suicidal Ideation
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Suicidal Ideation or Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS)
Self-Injurious Behavior, No Suicidal Attempt
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
PRIMARY outcome
Timeframe: Baseline up to Week 52Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions).
Brain MRIs were collected to assess for potential drug-related changes that might have constituted a safety concern. Findings suggestive of either vasogenic edema or intracranial hemorrhage were to be reported as AEs of special circumstance.
Outcome measures
| Measure |
AAB-003 1 mg/kg
n=3 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 Participants
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 0.5 mg/kg
n=6 Participants
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Any New Magnetic Resonance Imaging (MRI) Findings
|
1 participants
|
0 participants
|
0 participants
|
0 participants
|
1 participants
|
1 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 52Population: The safety analysis set included participants who received at least 1 infusion of study medication (including partial infusions); n=number of evaluable participants at the specified time point.
Number of participants with positive sample(s) in the ADA assay and in the neutralizing anti-drug antibodies (NAb) assay. An endpoint titer \>=6.64 corresponded to positive ADA category value. The number of participants who tested positive on 1 or more occasions is reported.
Outcome measures
| Measure |
AAB-003 1 mg/kg
n=3 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 Participants
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 0.5 mg/kg
n=6 Participants
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer
Baseline (n=6,3,12,10,8)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
Number of Participants With Positive Anti-Drug Antibodies (ADA) Titer
Week 52 (n=4,3,9,8,10,8)
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 52Population: The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.
ADAS-Cog is a structured scale that evaluates memory, orientation, attention, reasoning, language and constructional praxis. The ADAS-Cog comprises 11 items that are summed to a total score ranging from 0 to 70, with higher scores indicate greater cognitive impairment.
Outcome measures
| Measure |
AAB-003 1 mg/kg
n=3 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 Participants
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 0.5 mg/kg
n=6 Participants
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52
Baseline (n=6,3,12,10,12,9)
|
22.7 units on a scale
Standard Deviation 11.79
|
25.1 units on a scale
Standard Deviation 14.11
|
23.8 units on a scale
Standard Deviation 9.21
|
19.6 units on a scale
Standard Deviation 10.72
|
23.3 units on a scale
Standard Deviation 11.00
|
12.0 units on a scale
Standard Deviation 4.58
|
|
Change From Baseline in Alzheimer's Disease Assessment Scale-Cognitive Subscale (ADAS-Cog) Scores at Week 52
Change at Week 52 (n=4,3,9,8,10,8)
|
3.0 units on a scale
Standard Deviation 7.22
|
5.5 units on a scale
Standard Deviation 4.30
|
2.8 units on a scale
Standard Deviation 4.56
|
5.9 units on a scale
Standard Deviation 4.22
|
2.5 units on a scale
Standard Deviation 6.07
|
3.7 units on a scale
Standard Deviation 3.98
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 52Population: The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.
The DAD is a functional assessment comprised of 40 items (17 items related to self-care and 23 items involving instrumental activities of daily living). The DAD assessment is scored from 0 to 100; higher scores indicate better function.
Outcome measures
| Measure |
AAB-003 1 mg/kg
n=3 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 Participants
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 0.5 mg/kg
n=6 Participants
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52
Baseline (n=6,3,12,10,12,9)
|
73.3 units on a scale
Standard Deviation 7.64
|
69.5 units on a scale
Standard Deviation 23.82
|
72.4 units on a scale
Standard Deviation 27.11
|
78.3 units on a scale
Standard Deviation 19.48
|
81.1 units on a scale
Standard Deviation 16.25
|
83.7 units on a scale
Standard Deviation 12.50
|
|
Change From Baseline in Disability Assessment in Dementia (DAD) at Week 52
Change at Week 52 (n=4,3,9,8,10,9)
|
-9.7 units on a scale
Standard Deviation 6.43
|
-10.4 units on a scale
Standard Deviation 15.26
|
-7.5 units on a scale
Standard Deviation 6.72
|
-5.2 units on a scale
Standard Deviation 12.89
|
-14.3 units on a scale
Standard Deviation 20.51
|
-5.0 units on a scale
Standard Deviation 24.75
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 52Population: The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.
The NPI is an instrument used to assess changes of behavior that have appeared in a defined period of time in subjects with Alzheimer's Disease and other dementias. Twelve behavioral areas are assessed: delusions, apathy, hallucinations, disinhibition, agitation, irritability, depression, aberrant motor behavior, anxiety, nighttime behaviors, euphoria, appetite, and eating changes. The NPI score is based on frequency and severity of specific behaviors within these categories. Severity (1=Mild to 3=Severe), frequency (1=occasionally to 4=very frequently) scales recorded for each domain; frequency\*severity=each domain score (range 0-12). Total score=sum of each domain score (range 0-144); higher score=greater behavioral disturbances; negative change score from baseline=improvement.
Outcome measures
| Measure |
AAB-003 1 mg/kg
n=3 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 Participants
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 0.5 mg/kg
n=6 Participants
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52
Baseline (n=6,3,12,10,12,9)
|
12.0 units on a scale
Standard Deviation 13.45
|
7.1 units on a scale
Standard Deviation 6.99
|
11.0 units on a scale
Standard Deviation 16.73
|
9.6 units on a scale
Standard Deviation 10.24
|
3.9 units on a scale
Standard Deviation 3.92
|
11.2 units on a scale
Standard Deviation 7.65
|
|
Change From Baseline in Neuropsychiatric Inventory (NPI) Behavioral Symptoms at Week 52
Change at Week 52 (n=4,3,9,8,10,9)
|
5.7 units on a scale
Standard Deviation 1.15
|
5.1 units on a scale
Standard Deviation 8.39
|
4.5 units on a scale
Standard Deviation 8.90
|
0.1 units on a scale
Standard Deviation 12.54
|
13.9 units on a scale
Standard Deviation 23.00
|
-3.5 units on a scale
Standard Deviation 4.36
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 52Population: The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.
The CDR scale is a dementia staging instrument that tracks the progression of cognitive impairment in the following 6 categories: memory, orientation, judgment and problem solving, involvement in community affairs, home and hobbies, and personal care. The CDR-SB scale is obtained by summing the ratings in each of the 6 categories, ranging from 0 to 18. Higher scores indicate greater disease severity.
Outcome measures
| Measure |
AAB-003 1 mg/kg
n=3 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 Participants
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 0.5 mg/kg
n=6 Participants
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52
Baseline (n=6,3,12,10,12,9)
|
11.00 units on a scale
Standard Deviation 1.000
|
11.33 units on a scale
Standard Deviation 5.710
|
10.30 units on a scale
Standard Deviation 4.473
|
10.33 units on a scale
Standard Deviation 4.313
|
9.56 units on a scale
Standard Deviation 3.941
|
9.00 units on a scale
Standard Deviation 3.347
|
|
Change From Baseline in Clinical Dementia Rating Sum of Boxes (CDR-SB) Scores at Week 52
Change at Week 52 (n=4,3,9,8,10,9)
|
0.33 units on a scale
Standard Deviation 0.577
|
2.67 units on a scale
Standard Deviation 2.291
|
2.38 units on a scale
Standard Deviation 1.598
|
1.10 units on a scale
Standard Deviation 2.378
|
2.56 units on a scale
Standard Deviation 2.789
|
0.00 units on a scale
Standard Deviation 0.816
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, Week 52Population: The full analysis set included participants who were randomized and received at least 1 infusion of study medication; n=number of evaluable participants at the specified time point.
The MMSE is a brief 30-point questionnaire test that is used to assess cognition. Scores range from 0 to 30, with higher scores indicating better cognitive state.
Outcome measures
| Measure |
AAB-003 1 mg/kg
n=3 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 Participants
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 Participants
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 0.5 mg/kg
n=6 Participants
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52
Baseline (n=6,3,12,10,12,9)
|
21.0 units on a scale
Standard Deviation 4.36
|
19.3 units on a scale
Standard Deviation 5.05
|
18.5 units on a scale
Standard Deviation 4.86
|
21.3 units on a scale
Standard Deviation 5.40
|
18.9 units on a scale
Standard Deviation 5.64
|
24.7 units on a scale
Standard Deviation 1.86
|
|
Change From Baseline in Mini-Mental State Exam (MMSE) Scores at Week 52
Change at Week 52 (n=4,3,9,8,10,9)
|
1.7 units on a scale
Standard Deviation 1.15
|
-2.7 units on a scale
Standard Deviation 2.78
|
-2.1 units on a scale
Standard Deviation 1.64
|
-2.0 units on a scale
Standard Deviation 2.16
|
-1.7 units on a scale
Standard Deviation 3.91
|
-1.0 units on a scale
Standard Deviation 2.94
|
Adverse Events
AAB-003 0.5 mg/kg
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
AAB-003 1 mg/kg
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
AAB-003 2 mg/kg
Serious events: 2 serious events
Other events: 9 other events
Deaths: 0 deaths
AAB-003 4 mg/kg
Serious events: 3 serious events
Other events: 4 other events
Deaths: 0 deaths
AAB-003 8 mg/kg
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Placebo/AAB-003
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AAB-003 0.5 mg/kg
n=6 participants at risk
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 1 mg/kg
n=3 participants at risk
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 participants at risk
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 participants at risk
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 participants at risk
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 participants at risk
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
General disorders
Chest pain
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
General disorders
Device breakage
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Hepatobiliary disorders
bile duct stone
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
10.0%
1/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
10.0%
1/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Reproductive system and breast disorders
Uterine prolapse
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
10.0%
1/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
Other adverse events
| Measure |
AAB-003 0.5 mg/kg
n=6 participants at risk
Continued at same dose as preceding study B2601001 (NCT01369225), participants received intravenous (IV) infusion of AAB-003 (also known as PF-05236812) in a sterile vial at 0.5 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 1 mg/kg
n=3 participants at risk
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 1 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 2 mg/kg
n=12 participants at risk
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 2 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 4 mg/kg
n=10 participants at risk
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 4 mg/kg once every 13 weeks for up to 4 infusions.
|
AAB-003 8 mg/kg
n=12 participants at risk
Continued at same dose as preceding study B2601001, participants received IV infusion of AAB-003 in a sterile vial at 8 mg/kg once every 13 weeks for up to 4 infusions.
|
Placebo/AAB-003
n=9 participants at risk
Participants who received placebo in a preceding study B2601001 then received open-label active drug AAB-003. Subjects received either 0.5 mg/kg, 1 mg/kg, 2 mg/kg, 4mg/kg or 8 mg/kg once every 13 weeks for up to 4 infusions.
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Blood and lymphatic system disorders
Haemorrhagic anaemia
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
10.0%
1/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Ear and labyrinth disorders
Ear disorder
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Ear and labyrinth disorders
Hearing impaired
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Gastrointestinal disorders
Anorectal discomfort
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Gastrointestinal disorders
Diverticulum
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Gastrointestinal disorders
Food poisoning
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Gastrointestinal disorders
Rectal fissure
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
General disorders
Chest pain
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
General disorders
Gait disturbance
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
General disorders
Infusion site bruising
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
General disorders
Infusion site pain
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
General disorders
Infusion site swelling
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
10.0%
1/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
10.0%
1/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Infections and infestations
Eye infection
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
10.0%
1/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Infections and infestations
Urinary tract infection
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
16.7%
2/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Fall
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
66.7%
2/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Investigations
Abdominal bruit
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Investigations
aspartate aminotransferase increased
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Investigations
Blood albumin decreased
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Investigations
Blood potassium decreased
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Investigations
Blood pressure increased
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Investigations
Blood urea increased
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Investigations
Blood uric acid increased
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Investigations
Cardiac murmur
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Investigations
Carotid bruit
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Investigations
Platelet count increased
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Investigations
Protein total decreased
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Investigations
Weight decreased
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
10.0%
1/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Osteoporosis
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Posture abnormal
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Nervous system disorders
Cerebral infarction
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Nervous system disorders
Coordination abnormal
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
16.7%
2/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Nervous system disorders
Head discomfort
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Nervous system disorders
Headache
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Nervous system disorders
Hypokinesia
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
10.0%
1/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Nervous system disorders
Lacunar infarction
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Nervous system disorders
Parkinsonian gait
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Nervous system disorders
Postural tremor
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Psychiatric disorders
Aggression
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Psychiatric disorders
Agitation
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
16.7%
2/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Psychiatric disorders
Apathy
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Psychiatric disorders
Delusion
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
25.0%
3/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
22.2%
2/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Psychiatric disorders
Hypersexuality
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Psychiatric disorders
Hypnopompic hallucination
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Psychiatric disorders
Nervousness
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Renal and urinary disorders
Diabetic nephropathy
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
10.0%
1/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
10.0%
1/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
16.7%
2/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Reproductive system and breast disorders
Breast cyst
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Reproductive system and breast disorders
Breast tenderness
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Reproductive system and breast disorders
Vulvovaginal burning sensation
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
10.0%
1/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
16.7%
1/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Solar lentigo
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
11.1%
1/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Vascular disorders
Haematoma
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
33.3%
1/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Infections and infestations
Furuncle
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
8.3%
1/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
|
Nervous system disorders
Quadranopia
|
0.00%
0/6 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/3 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
10.0%
1/10 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/12 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
0.00%
0/9 • Baseline up to Week 52
The same event may appear as both an AE and an SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and a non-serious event during the study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER