Trial Outcomes & Findings for A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF) (NCT NCT03832946)
NCT ID: NCT03832946
Last Updated: 2024-05-22
Results Overview
Efficacy of GB0139 as measured by the annual rate of decline in FVC expressed in mL
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
172 participants
Primary outcome timeframe
52 weeks
Results posted on
2024-05-22
Participant Flow
Participant milestones
| Measure |
A. GB0139 3 mg Once a Day
Inhalation of GB0139
GB0139: GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.
|
B. Placebo Once a Day
Inhalation of Placebo
Placebo: Placebo is administered as inhalation once a day
|
|---|---|---|
|
Overall Study
STARTED
|
102
|
70
|
|
Overall Study
COMPLETED
|
55
|
38
|
|
Overall Study
NOT COMPLETED
|
47
|
32
|
Reasons for withdrawal
| Measure |
A. GB0139 3 mg Once a Day
Inhalation of GB0139
GB0139: GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.
|
B. Placebo Once a Day
Inhalation of Placebo
Placebo: Placebo is administered as inhalation once a day
|
|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Change in Protocol forbidding use of Nintedanib / Pirfenidone
|
30
|
22
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
12
|
9
|
Baseline Characteristics
A Study to Test the Efficacy and Safety of Inhaled GB0139 in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Baseline characteristics by cohort
| Measure |
A. GB0139 3 mg Once a Day
n=102 Participants
Inhalation of GB0139
GB0139: GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.
|
B. Placebo Once a Day
n=70 Participants
Inhalation of Placebo
Placebo: Placebo is administered as inhalation once a day
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.5 years
STANDARD_DEVIATION 7.59 • n=5 Participants
|
71.7 years
STANDARD_DEVIATION 7.36 • n=7 Participants
|
72.176 years
STANDARD_DEVIATION 7.48 • n=5 Participants
|
|
Age, Customized
Age, Categorical · <70
|
34 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Age, Customized
Age, Categorical · >=70
|
68 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
27 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
123 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
95 Participants
n=5 Participants
|
63 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
98 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
167 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
24 participants
n=7 Participants
|
48 participants
n=5 Participants
|
|
Region of Enrollment
Ukraine
|
4 participants
n=5 Participants
|
2 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
27 participants
n=5 Participants
|
15 participants
n=7 Participants
|
42 participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
1 participants
n=5 Participants
|
4 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Ireland
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
1 participants
n=5 Participants
|
2 participants
n=7 Participants
|
3 participants
n=5 Participants
|
|
Region of Enrollment
Georgia
|
8 participants
n=5 Participants
|
1 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
10 participants
n=5 Participants
|
5 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
8 participants
n=5 Participants
|
1 participants
n=7 Participants
|
9 participants
n=5 Participants
|
|
Region of Enrollment
France
|
4 participants
n=5 Participants
|
3 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Region of Enrollment
Germany
|
2 participants
n=5 Participants
|
4 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Russia
|
6 participants
n=5 Participants
|
2 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
Forced Vital Capacity (FVC) in mL
|
3003.1 mL
STANDARD_DEVIATION 861.58 • n=5 Participants
|
2859.1 mL
STANDARD_DEVIATION 876.13 • n=7 Participants
|
2944.5 mL
STANDARD_DEVIATION 867.88 • n=5 Participants
|
PRIMARY outcome
Timeframe: 52 weeksEfficacy of GB0139 as measured by the annual rate of decline in FVC expressed in mL
Outcome measures
| Measure |
A. GB0139 3 mg Once a Day
n=100 Participants
Inhalation of GB0139
GB0139: GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.
|
B. Placebo Once a Day
n=68 Participants
Inhalation of Placebo
Placebo: Placebo is administered as inhalation once a day
|
|---|---|---|
|
Annual Rate of Decline in Forced Vital Capacity (FVC)
|
-316.60 mL/Year
Interval -394.86 to -238.35
|
-127.41 mL/Year
Interval -221.12 to -33.71
|
SECONDARY outcome
Timeframe: 52 weeksNumber of Participants with Respiratory Related Hospitalizations from randomisation (including acute exacerbation of IPF).
Outcome measures
| Measure |
A. GB0139 3 mg Once a Day
n=102 Participants
Inhalation of GB0139
GB0139: GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.
|
B. Placebo Once a Day
n=70 Participants
Inhalation of Placebo
Placebo: Placebo is administered as inhalation once a day
|
|---|---|---|
|
Number of Participants With Respiratory Related Hospitalizations
|
17 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: 52 weeksChange from baseline to WK52 in the SGRQ total score. The SGRQ is a 50-item questionnaire split into three domains: symptoms, activity and impact. Weighting of both individual domains and the total score produces a range from 0 to 100, with higher scores indicating a poorer health-related quality of life.
Outcome measures
| Measure |
A. GB0139 3 mg Once a Day
n=68 Participants
Inhalation of GB0139
GB0139: GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.
|
B. Placebo Once a Day
n=48 Participants
Inhalation of Placebo
Placebo: Placebo is administered as inhalation once a day
|
|---|---|---|
|
Assessment of Respiratory Related Quality of Life Using the St. George's Respiratory Questionnaire (SGRQ)
|
4.201 score on a scale
Standard Deviation 20.0648
|
-4.77 score on a scale
Standard Deviation 14.7286
|
Adverse Events
A. GB0139 3 mg Once a Day
Serious events: 24 serious events
Other events: 80 other events
Deaths: 8 deaths
B. Placebo Once a Day
Serious events: 11 serious events
Other events: 50 other events
Deaths: 5 deaths
Serious adverse events
| Measure |
A. GB0139 3 mg Once a Day
n=102 participants at risk
Inhalation of GB0139
GB0139: GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.
|
B. Placebo Once a Day
n=70 participants at risk
Inhalation of Placebo
Placebo: Placebo is administered as inhalation once a day
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
7.8%
8/102 • Number of events 10 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.0%
2/102 • Number of events 3 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
COVID-19
|
3.9%
4/102 • Number of events 4 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Pneumonia
|
3.9%
4/102 • Number of events 4 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
COVID-19 pneumonia
|
2.0%
2/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Sepsis
|
2.0%
2/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Septic Shock
|
2.0%
2/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Coronavirus infection
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Localised Infection
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Angina pectoris
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Cardiac arrest
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Coronary artery disease
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Ventricular fibrillation
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
General disorders
Fatigue
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
General disorders
Hyperthermia
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
General disorders
Necrosis
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
General disorders
Sudden Death
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung neoplasm malignant
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to skin
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine tumour of the lung
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Abdominal Injury
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Nervous system disorders
Cerebral microangiopathy
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Nervous system disorders
Cerebrovascular accident
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Nervous system disorders
Ischaemic stroke
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Blood and lymphatic system disorders
Pernicious anaemia
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Renal and urinary disorders
Acute kidney injury
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Vascular disorders
Peripheral ischaemia
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
Other adverse events
| Measure |
A. GB0139 3 mg Once a Day
n=102 participants at risk
Inhalation of GB0139
GB0139: GB0139 is a galectin-3 inhibitor designed to modulate the fibrogenic response to tissue injury. It is administered as inhalation once a day.
|
B. Placebo Once a Day
n=70 participants at risk
Inhalation of Placebo
Placebo: Placebo is administered as inhalation once a day
|
|---|---|---|
|
Infections and infestations
Lower Respiratory Tract Infection
|
11.8%
12/102 • Number of events 19 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
4.3%
3/70 • Number of events 3 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Upper respiratory tract infection
|
4.9%
5/102 • Number of events 6 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
5.7%
4/70 • Number of events 4 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
4/102 • Number of events 7 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
4.3%
3/70 • Number of events 4 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Bronchitis
|
5.9%
6/102 • Number of events 8 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
4.3%
3/70 • Number of events 4 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Urinary Tract Infection
|
4.9%
5/102 • Number of events 8 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Tooth Abcess
|
2.9%
3/102 • Number of events 3 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Tooth Infection
|
2.0%
2/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Gastroenteritis
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Tracheitis
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Acarodermatitis
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Bronchitis Bacterial
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Coronavirus Infection
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Cystitis
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Gingivitis
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Helicobacter infection
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Influenza
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Oral Herpes
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Pharyngitis
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Root Canal Infection
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Viral Infection
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Viral Upper Respiratory Tract Infection
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
16.7%
17/102 • Number of events 24 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
12.9%
9/70 • Number of events 9 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Productive Cough
|
5.9%
6/102 • Number of events 6 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
2.9%
2/70 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.9%
3/102 • Number of events 3 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
2.9%
3/102 • Number of events 3 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.98%
1/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.0%
2/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Sputum Increased
|
2.0%
2/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary mass
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Sputum Discoloured
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
General disorders
Oedema Peripheral
|
3.9%
4/102 • Number of events 4 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
2.9%
2/70 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
General disorders
Asthenia
|
3.9%
4/102 • Number of events 4 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
General disorders
Pyrexia
|
2.0%
2/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
General disorders
Malaise
|
0.98%
1/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
General disorders
Vaccination Site Pain
|
0.98%
1/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
General disorders
Feeling Cold
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
General disorders
Influenza Like Illness
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
General disorders
Vaccination Site Rash
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
4.9%
5/102 • Number of events 5 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
4.3%
3/70 • Number of events 3 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.9%
3/102 • Number of events 3 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
2.9%
2/70 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
2.0%
2/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
2.9%
2/70 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Musculoskeletal and connective tissue disorders
Chest wall haematoma
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Musculoskeletal and connective tissue disorders
Joint Stiffness
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Musculoskeletal and connective tissue disorders
Joint Swelling
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Musculoskeletal and connective tissue disorders
Limb Mass
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal discomfort
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Musculoskeletal and connective tissue disorders
Polymyalgia rheumatica
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Diarrhoea
|
7.8%
8/102 • Number of events 13 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
2.9%
2/70 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Constipation
|
3.9%
4/102 • Number of events 4 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Nausea
|
2.9%
3/102 • Number of events 6 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Abdominal pain
|
2.0%
2/102 • Number of events 3 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
2.9%
3/102 • Number of events 3 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Flatulence
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Vomiting
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.98%
1/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Abdominal distension
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Dyspepsia
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Eructation
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Gingival cyst
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Gastrointestinal disorders
Reflux gastritis
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Nervous system disorders
Headache
|
6.9%
7/102 • Number of events 7 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
2.9%
2/70 • Number of events 5 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Nervous system disorders
Dizziness
|
3.9%
4/102 • Number of events 4 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
2.9%
2/70 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Nervous system disorders
Sciatica
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Nervous system disorders
Essential Tremor
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Nervous system disorders
Hemiparesis
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Nervous system disorders
Lethargy
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Nervous system disorders
Memory impairment
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Nervous system disorders
Mental Impairment
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Nervous system disorders
Neuropathy peripheral
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Nervous system disorders
Paraesthesia
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Nervous system disorders
Presyncope
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Nervous system disorders
Sensory loss
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Nervous system disorders
Tremor
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Atrial Fibrillation
|
2.0%
2/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Tachycardia
|
2.0%
2/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Cardiac failure
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Arteriosclerosis coronary artery
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Atrioventricular block first degree
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Bradycardia
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Bundle branch block left
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Myocardial hypoxia
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Palpitations
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Sinus bradycardia
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
3.9%
4/102 • Number of events 4 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
4.3%
3/70 • Number of events 3 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Metabolism and nutrition disorders
Gout
|
2.0%
2/102 • Number of events 3 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Metabolism and nutrition disorders
Folate Deficiency
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Metabolism and nutrition disorders
Hyperkalaemia
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Metabolism and nutrition disorders
Increased Appetite
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Metabolism and nutrition disorders
Iron deficiency
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Fall
|
2.9%
3/102 • Number of events 5 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Vaccination Complication
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 3 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Limb Injury
|
2.0%
2/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Skin Laceration
|
2.0%
2/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Contusion
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Eye Injury
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Eyelid contusion
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Muscle Injury
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Procedural Pain
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Road Traffic Accident
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Soft Tissue Injury
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Investigations
Weight Decreased
|
3.9%
4/102 • Number of events 4 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
4.3%
3/70 • Number of events 3 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Investigations
Forced vital capacity decreased
|
2.0%
2/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
2.9%
2/70 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Investigations
Anticoagulation drug level above therapeutic
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Investigations
Blood glucose increased
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Investigations
Heart rate increased
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Investigations
Occult blood positive
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal Cell Carcinoma
|
2.0%
2/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Monoclonal Gammopathy
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Vascular disorders
Hypertension
|
2.9%
3/102 • Number of events 3 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Vascular disorders
Hypotension
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Vascular disorders
Aortic arteriosclerosis
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Vascular disorders
Haematoma
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Psychiatric disorders
Anxiety
|
2.9%
3/102 • Number of events 3 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Psychiatric disorders
Insomnia
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
2.9%
2/70 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Psychiatric disorders
Restlessness
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Psychiatric disorders
Sleep disorder
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Psychiatric disorders
Suicidal ideation
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Skin and subcutaneous tissue disorders
Rash
|
2.0%
2/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Eye disorders
Cataract
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Eye disorders
Dry eye
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Eye disorders
Epiretinal membrane
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Eye disorders
Episcleritis
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Eye disorders
Eye haematoma
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Eye disorders
Eye pain
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Renal and urinary disorders
Renal Cyst
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Renal and urinary disorders
Renal Failure
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
2.9%
2/70 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Immune system disorders
Autoimmune disorder
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Reproductive system and breast disorders
Prostatic atrophy
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Reproductive system and breast disorders
Prostatomegaly
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Ear and labyrinth disorders
Excessive cerumen production
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Ear and labyrinth disorders
Vertigo positional
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Endocrine disorders
Goitre
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Endocrine disorders
Hypothyroidism
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Idiopathic pulmonary fibrosis
|
4.9%
5/102 • Number of events 6 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
4.3%
3/70 • Number of events 3 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.8%
11/102 • Number of events 14 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
7.1%
5/70 • Number of events 5 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
COVID-19
|
12.7%
13/102 • Number of events 14 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
4.3%
3/70 • Number of events 4 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Pneumonia
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
COVID-19 Pneumonia
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Cellulitis
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Infections and infestations
Localised Infection
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
General disorders
Fatigue
|
2.0%
2/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
7.1%
5/70 • Number of events 5 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Cardiac disorders
Coronary artery disease
|
0.98%
1/102 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Injury, poisoning and procedural complications
Rib Fracture
|
0.98%
1/102 • Number of events 2 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
0.00%
0/70 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
|
Renal and urinary disorders
Acute Kidney Injury
|
0.00%
0/102 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
1.4%
1/70 • Number of events 1 • 52 weeks (Includes all AEs with a start date up to and including Day 379 (52 weeks + 14 days)
|
Additional Information
Hans Schambye - Chief Executive Officer
Galecto Biotech aps
Phone: +4526373726
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Investigators must agree to maintain the confidentiality of the study at all times and must not reveal any information relating to the study without express permission from the study Sponsor.
- Publication restrictions are in place
Restriction type: OTHER