Trial Outcomes & Findings for Safety and Efficacy of IMM 124-E for Patients With Severe Alcoholic Hepatitis (NCT NCT01968382)
NCT ID: NCT01968382
Last Updated: 2020-01-27
Results Overview
Number of events and severity of gastrointestinal events, including nausea, vomiting, and diarrhea
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
57 participants
Primary outcome timeframe
30 Days
Results posted on
2020-01-27
Participant Flow
Participant milestones
| Measure |
IMM 124-E 2400 mg/Day
Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
IMM 124-E 4800 mg/Day
Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
|
Placebo (High Protein Milk Powder)
Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
19
|
20
|
|
Overall Study
COMPLETED
|
18
|
19
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of IMM 124-E for Patients With Severe Alcoholic Hepatitis
Baseline characteristics by cohort
| Measure |
IMM 124-E 2400 mg/Day
n=18 Participants
Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
IMM 124-E 4800 mg/Day
n=19 Participants
Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
|
Placebo (High Protein Milk Powder)
n=20 Participants
Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
Total
n=57 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
43.5 years
STANDARD_DEVIATION 10.2 • n=99 Participants
|
44.4 years
STANDARD_DEVIATION 11 • n=107 Participants
|
45.7 years
STANDARD_DEVIATION 11.8 • n=206 Participants
|
44.6 years
STANDARD_DEVIATION 10.9 • n=157 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
26 Participants
n=157 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
31 Participants
n=157 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
4 Participants
n=157 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
48 Participants
n=157 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
3 Participants
n=157 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=157 Participants
|
|
Region of Enrollment
United States
|
18 participants
n=99 Participants
|
19 participants
n=107 Participants
|
20 participants
n=206 Participants
|
57 participants
n=157 Participants
|
PRIMARY outcome
Timeframe: 30 DaysNumber of events and severity of gastrointestinal events, including nausea, vomiting, and diarrhea
Outcome measures
| Measure |
IMM 124-E 2400 mg/Day
n=18 Participants
Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
IMM 124-E 4800 mg/Day
n=19 Participants
Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
|
Placebo (High Protein Milk Powder)
n=20 Participants
Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
|---|---|---|---|
|
Gastrointestinal Safety Endpoints
Mild
|
15 Incidents
|
27 Incidents
|
7 Incidents
|
|
Gastrointestinal Safety Endpoints
Moderate
|
14 Incidents
|
25 Incidents
|
18 Incidents
|
|
Gastrointestinal Safety Endpoints
Severe
|
5 Incidents
|
3 Incidents
|
6 Incidents
|
PRIMARY outcome
Timeframe: 30 DaysNumber of incidents of the following: renal failure, encephalopathy or pulmonary compromise.
Outcome measures
| Measure |
IMM 124-E 2400 mg/Day
n=18 Participants
Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
IMM 124-E 4800 mg/Day
n=19 Participants
Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
|
Placebo (High Protein Milk Powder)
n=20 Participants
Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
|---|---|---|---|
|
Combined Kidney, Brain, and Lung Safety Endpoints
Renal failure
|
9 incidents
|
10 incidents
|
11 incidents
|
|
Combined Kidney, Brain, and Lung Safety Endpoints
Encephalopathy
|
0 incidents
|
1 incidents
|
0 incidents
|
|
Combined Kidney, Brain, and Lung Safety Endpoints
Pulmonary compromise
|
5 incidents
|
6 incidents
|
8 incidents
|
PRIMARY outcome
Timeframe: 30 DaysNumber of incidents of sepsis.
Outcome measures
| Measure |
IMM 124-E 2400 mg/Day
n=18 Participants
Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
IMM 124-E 4800 mg/Day
n=19 Participants
Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
|
Placebo (High Protein Milk Powder)
n=20 Participants
Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
|---|---|---|---|
|
Infection Safety Endpoints
|
2 Incidents
|
1 Incidents
|
2 Incidents
|
PRIMARY outcome
Timeframe: 30 DaysNumber of incidents of all other serious adverse events and other adverse events not already assessed as a primary outcome.
Outcome measures
| Measure |
IMM 124-E 2400 mg/Day
n=18 Participants
Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
IMM 124-E 4800 mg/Day
n=19 Participants
Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
|
Placebo (High Protein Milk Powder)
n=20 Participants
Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
|---|---|---|---|
|
Other Safety Endpoints
|
67 Events
|
113 Events
|
124 Events
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: Data were not collected separately for participants who suffered diarrhea. All gastrointestinal events (including diarrhea) were recorded as generic gastrointestinal events and reported in primary outcome #1.
Number of participants who experience diarrhea
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, day 28Changes in endotoxin levels as measured using a standard blood assay
Outcome measures
| Measure |
IMM 124-E 2400 mg/Day
n=18 Participants
Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
IMM 124-E 4800 mg/Day
n=19 Participants
Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
|
Placebo (High Protein Milk Powder)
n=20 Participants
Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
|---|---|---|---|
|
Change in Circulating Endotoxin Levels
|
-361.06 ng/mL
Standard Deviation 1249.17
|
-72.94 ng/mL
Standard Deviation 755.23
|
123.41 ng/mL
Standard Deviation 469.38
|
SECONDARY outcome
Timeframe: 7 daysNumber of participants who meet Lille criteria indicating failure to respond to treatment
Outcome measures
| Measure |
IMM 124-E 2400 mg/Day
n=17 Participants
Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
IMM 124-E 4800 mg/Day
n=19 Participants
Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
|
Placebo (High Protein Milk Powder)
n=19 Participants
Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
|---|---|---|---|
|
Lille Model Score
|
5 Participants
|
6 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 180 daysNumber of deaths due to any cause
Outcome measures
| Measure |
IMM 124-E 2400 mg/Day
n=18 Participants
Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
IMM 124-E 4800 mg/Day
n=19 Participants
Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
|
Placebo (High Protein Milk Powder)
n=20 Participants
Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
|---|---|---|---|
|
Mortality
|
5 Participants
|
2 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: 90 daysModel for end-stage liver disease (MELD) score ranges from 6 to 40 with higher number indicating worse liver function.
Outcome measures
| Measure |
IMM 124-E 2400 mg/Day
n=9 Participants
Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
IMM 124-E 4800 mg/Day
n=11 Participants
Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
|
Placebo (High Protein Milk Powder)
n=9 Participants
Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
|---|---|---|---|
|
Change in Liver Function
|
-8.89 score on a scale
Standard Deviation 5.35
|
-6.82 score on a scale
Standard Deviation 4.87
|
-7.78 score on a scale
Standard Deviation 12.12
|
SECONDARY outcome
Timeframe: 30 daysPopulation: Data not collected
SOFA is a single score based on patient status of six different biological systems: respiratory, cardiovascular, hepatic, coagulation, renal, and neurological. Scores range from 0 to 24 with higher scores indicated worse status.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to 90 daysPopulation: Data not collected
Serum bile acids levels as measured using standard blood serum assay
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 180 daysPopulation: Data not collected
Length of time to a drop in bilirubin of 50% measured in days
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 28 daysPopulation: Data not collected
Changes in cytokine profile across study arms at day 28
Outcome measures
Outcome data not reported
Adverse Events
IMM 124-E 2400 mg/Day
Serious events: 11 serious events
Other events: 18 other events
Deaths: 5 deaths
IMM 124-E 4800 mg/Day
Serious events: 9 serious events
Other events: 19 other events
Deaths: 2 deaths
Placebo (High Protein Milk Powder)
Serious events: 12 serious events
Other events: 17 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
IMM 124-E 2400 mg/Day
n=18 participants at risk
Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
IMM 124-E 4800 mg/Day
n=19 participants at risk
Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
|
Placebo (High Protein Milk Powder)
n=20 participants at risk
Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
|---|---|---|---|
|
Metabolism and nutrition disorders
hypokalaemia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
General disorders
perforated ulcer
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Nervous system disorders
hepatic encephalopathy
|
16.7%
3/18 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.0%
3/20 • Number of events 4 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
sepsis
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Respiratory, thoracic and mediastinal disorders
acute respiratory failure
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.0%
3/20 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
lactic acidosis
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Psychiatric disorders
alcohol withdrawal syndrome
|
5.6%
1/18 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
metabolic acidosis
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
General disorders
oedema peripheral
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Investigations
blood creatinine abnormal
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Nervous system disorders
Encephalopathy
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Social circumstances
alcohol use
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Hepatobiliary disorders
alcoholic liver disease
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Injury, poisoning and procedural complications
idiosyncratic alcohol intoxication
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
hyponatraemia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
peritonitis bacterial
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Renal and urinary disorders
renal failure acute
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Vascular disorders
hypotension
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
gastrointestinal bacterial infection
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
septic shock
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Hepatobiliary disorders
hepatic cirrhosis
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Renal and urinary disorders
renal injury
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Hepatobiliary disorders
hyperbilirubinaemia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Blood and lymphatic system disorders
leukocytosis
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
fluid imbalance
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Surgical and medical procedures
endotracheal intubation
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Hepatobiliary disorders
hepatorenal syndrome
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
General disorders
multi-organ failure
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
abdominal pain
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 5 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Investigations
blood glucose increased
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
dehydration
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Hepatobiliary disorders
cirrhosis alcoholic
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
upper gastrointestinal haemorrhage
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
ascites
|
5.6%
1/18 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
pneumoperitoneum
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Surgical and medical procedures
explorative laparotomy
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
large intestine perforation
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
hypercalcaemia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Hepatobiliary disorders
hepatic function abnormal
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
pneumonia fungal
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Surgical and medical procedures
liver transplant
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Respiratory, thoracic and mediastinal disorders
hypoxia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Respiratory, thoracic and mediastinal disorders
lobar pneumonia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Respiratory, thoracic and mediastinal disorders
hepatic hydrothorax
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
General disorders
systemic inflammatory response syndrome
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Psychiatric disorders
mental status changes
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Nervous system disorders
headache
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
chronic gastrointestinal bleeding
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
General disorders
generalised oedema
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Surgical and medical procedures
alcohol detoxification
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
pancreatitis
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
skin infection
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
abdominal infection
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
Other adverse events
| Measure |
IMM 124-E 2400 mg/Day
n=18 participants at risk
Imm-124-E (2400 mg/day) will be provided in two divided doses daily in the form of powder to be mixed with water. Subjects will get 1 active drug powder and 1 placebo powder with each dosing for a total of 4 sachets daily.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
IMM 124-E 4800 mg/Day
n=19 participants at risk
Imm-124-E (4800 mg/day) will be provided in two divided doses daily in the form of 2400 mg in the form of a powder to be mixed with water. The total number daily will be 4 sachets.
IMM 124-E (Hyperimmune Bovine Colostrum): Hyper-immune bovine colostrum enriched with anti-LPS antibodies and which has been designated by Immuron as IMM-124E.
|
Placebo (High Protein Milk Powder)
n=20 participants at risk
Subjects will receive 2 sachets of placebo powder to be mixed with water in the morning and 2 sachets of placebo powder (to be mixed with water) in the evening for a total of 4 sachets of placebo daily.
Placebo (High protein milk powder): Subjects will receive a total of 4 sachets (2 in the morning and 2 in the evening) daily
|
|---|---|---|---|
|
Infections and infestations
urinary tract infection
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
General disorders
Oedema
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Renal and urinary disorders
renal injury
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
25.0%
5/20 • Number of events 5 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Vascular disorders
phlebitis
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
diarrhoea
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
26.3%
5/19 • Number of events 5 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
hypoglycaemia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Nervous system disorders
dizziness
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Nervous system disorders
dysgeusia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
hypokalaemia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
cellulitis
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.8%
3/19 • Number of events 5 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Injury, poisoning and procedural complications
laceration
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Injury, poisoning and procedural complications
contusion
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Skin and subcutaneous tissue disorders
acne
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
diabetes mellitus
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Psychiatric disorders
psychogenic seizure
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
abdominal distension
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Injury, poisoning and procedural complications
compression fracture
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Musculoskeletal and connective tissue disorders
osteopenia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
abdominal discomfort
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Investigations
transaminases increased
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
portal hypertensive gastropathy
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
infective exacerbation of bronchiectasis
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
varices oesophageal
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
oral fungal infection
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Injury, poisoning and procedural complications
muscle strain
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Blood and lymphatic system disorders
leukocytosis
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.8%
3/19 • Number of events 4 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
20.0%
4/20 • Number of events 4 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Congenital, familial and genetic disorders
protein c deficiency
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Vascular disorders
hypotension
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
metabolic acidosis
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
fungal skin infection
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Injury, poisoning and procedural complications
excoriation
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Respiratory, thoracic and mediastinal disorders
atelectasis
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
calciphylaxis
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Skin and subcutaneous tissue disorders
skin necrosis
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Investigations
body temperature increased
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
General disorders
oedema peripheral
|
22.2%
4/18 • Number of events 6 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
26.3%
5/19 • Number of events 9 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
25.0%
5/20 • Number of events 6 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Surgical and medical procedures
central venous catheterisation
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Surgical and medical procedures
bladder catheterisation
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
constipation
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
oral candidiasis
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Surgical and medical procedures
debridement
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Investigations
antiphospholipid antibodies positive
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Hepatobiliary disorders
portal hypertension
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Hepatobiliary disorders
cholecystitis acute
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Surgical and medical procedures
lesion excision
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
acidosis
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Psychiatric disorders
mental status changes
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Investigations
culture wound positive
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
malnutrition
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Injury, poisoning and procedural complications
skin wound
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Skin and subcutaneous tissue disorders
pruritus
|
16.7%
3/18 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.0%
3/20 • Number of events 4 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
bowel movement irregularity
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Renal and urinary disorders
urinary incontinence
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
hypovitaminosis
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Reproductive system and breast disorders
nipple pain
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
General disorders
chills
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.8%
3/19 • Number of events 4 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Nervous system disorders
tremor
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
dyspepsia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Respiratory, thoracic and mediastinal disorders
respiratory disorder
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
General disorders
fatigue
|
16.7%
3/18 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
21.1%
4/19 • Number of events 4 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Musculoskeletal and connective tissue disorders
muscular weakness
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Musculoskeletal and connective tissue disorders
joint stiffness
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
tongue abscess
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
flatulence
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
11.1%
2/18 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Investigations
hyperammonaemia
|
16.7%
3/18 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal pain
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
abdominal pain
|
16.7%
3/18 • Number of events 4 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
26.3%
5/19 • Number of events 7 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
General disorders
hyperthermia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
ascites
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Nervous system disorders
asterixis
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Musculoskeletal and connective tissue disorders
back pain
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Blood and lymphatic system disorders
jaundice
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Renal and urinary disorders
haematuria
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Skin and subcutaneous tissue disorders
blister
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Psychiatric disorders
insomnia
|
16.7%
3/18 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
oral pain
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
gingivitis
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
parotid gland enlargement
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Psychiatric disorders
alcohol withdrawal syndrome
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Respiratory, thoracic and mediastinal disorders
dyspnoea
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 4 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Skin and subcutaneous tissue disorders
ecchymosis
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Investigations
blood creatinine increased
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Investigations
glomerular filtration rate abnormal
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
cachexia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
vomiting
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.8%
3/19 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Skin and subcutaneous tissue disorders
skin lesion
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Nervous system disorders
hepatic encephalopathy
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.0%
3/20 • Number of events 4 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
hyperkalaemia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Investigations
lipase abnormal
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Investigations
blood alkaline phosphatase increased
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Skin and subcutaneous tissue disorders
drug reaction with eosinophilia and systemic symptoms
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
General disorders
malaise
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Renal and urinary disorders
renal failure acute
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Respiratory, thoracic and mediastinal disorders
pleural effusion
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
hyponatraemia
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
hypoalbuminaemia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Blood and lymphatic system disorders
coagulopathy
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Nervous system disorders
peripheral neuropathy
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Investigations
blood bilirubin increased
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Nervous system disorders
presyncope
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Psychiatric disorders
hallucination, visual
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
abnormal weight gain
|
16.7%
3/18 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Cardiac disorders
sinus tachycardia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Eye disorders
vision blurred
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Skin and subcutaneous tissue disorders
skin striae
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Nervous system disorders
lethargy
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.0%
2/20 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Psychiatric disorders
agitation
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Renal and urinary disorders
polyuria
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
polydipsia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Injury, poisoning and procedural complications
fall
|
11.1%
2/18 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
epigastric discomfort
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Investigations
urine bilirubin increased
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Investigations
weight decreased
|
11.1%
2/18 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Psychiatric disorders
depression
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Renal and urinary disorders
oliguria
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Psychiatric disorders
hallucination, auditory
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
hypercalcaemia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
hypomagnesaemia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
hypophosphataemia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Endocrine disorders
hypothyroidism
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Blood and lymphatic system disorders
anaemia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
15.0%
3/20 • Number of events 3 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Nervous system disorders
headache
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
10.5%
2/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
herpes dermatitis
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
bronchitis
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
hyperglycaemia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 2 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
pancreatitis
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Investigations
blood lactate dehydrogenase increased
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Psychiatric disorders
suicidal ideation
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Blood and lymphatic system disorders
pancytopenia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
brain abscess
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Nervous system disorders
seizure like phenomena
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
lactic acidosis
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
General disorders
pyrexia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Metabolism and nutrition disorders
hyperphosphataemia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Nervous system disorders
memory impairment
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Blood and lymphatic system disorders
thrombocytopenia
|
5.6%
1/18 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
haematochezia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Psychiatric disorders
anxiety
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Respiratory, thoracic and mediastinal disorders
nasal inflammation
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Renal and urinary disorders
bladder pain
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Reproductive system and breast disorders
amenorrhoea
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Skin and subcutaneous tissue disorders
spider naevus
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Skin and subcutaneous tissue disorders
alopecia
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Endocrine disorders
adrenal insufficiency
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Infections and infestations
Coxsackie viral infection
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Gastrointestinal disorders
haemorrhoids
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.3%
1/19 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/20 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Congenital, familial and genetic disorders
hyper IgE syndrome
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Hepatobiliary disorders
intrahepatic portal hepatic venous fistula
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
|
Musculoskeletal and connective tissue disorders
musculoskeletal chest pain
|
0.00%
0/18 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
0.00%
0/19 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
5.0%
1/20 • Number of events 1 • Adverse events were collected from the start of treatment until 24 weeks following the initial dose of study medication.
An adverse event is any untoward medical occurrence in a subject participating in a clinical trial. This includes any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication, whether or not considered related to the study medication. This definition also includes accidental injuries, reasons for any change in medication, reasons for hospital admission, or reasons for surgical procedures.
|
Additional Information
Stephanie Taylor MSN, RN
Virginia Commonwealth University
Phone: 804-828-9311
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place