Trial Outcomes & Findings for Efficacy and Safety Dose Finding Study of Givinostat to Treat Polyarticular Course Juvenile Idiopathic Arthritis (NCT NCT01261624)
NCT ID: NCT01261624
Last Updated: 2014-04-16
Results Overview
ACR Pediatric variables include: Physician's Global Assessment of disease activity on a 0-100 mm visual analogue scale from 0 mm = no disease activity to 100 mm = very severe disease activity; Parent's or patient's Global Assessment of Patient's overall well-being on a 100 mm VAS from 0 mm = very well to 100 mm = very poor; Functional ability: Childhood Health Assessment Questionnaire; Number of joints with active arthritis using the ACR definition (any joint with swelling, or in the absence of swelling, limitation of motion accompanied by pain/tenderness not due to bone deformity); Number of joints with limitation of motion; Laboratory measure of inflammation: C-reactive protein (mg/L) Patients were considered as responders if they achieve at least an ACR Pediatric Criteria level 30 of response, defined as a 30% improvement as compared to baseline in at least 3 of the 6 variables listed above, with no more than 1 variable worsening by \> than 30%
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
16 participants
Primary outcome timeframe
12 weeks of treatment
Results posted on
2014-04-16
Participant Flow
Recruitment period: October 2010 - December 2011. The study was conducted by nine Investigators in five countries across Europe; three Investigators in Italy, two Investigators each in Romania and Serbia, and one Investigator each in Czech Republic and Slovenia
Participant milestones
| Measure |
Low Dose Treatment Cohort (LDTC): 0.50 mg/kg Twice Daily (BID)
Patients (pts) received the dose of 0.50 mg/kg BID for 12 weeks in fed condition
|
High Dose Treatment Cohort (HDTC): 0.75 mg/kg BID
Patients received the dose of 0.75 mg/kg BID for 12 weeks in fed conditions
|
|---|---|---|
|
Week 0 to Week 12
STARTED
|
10
|
6
|
|
Week 0 to Week 12
COMPLETED
|
9
|
3
|
|
Week 0 to Week 12
NOT COMPLETED
|
1
|
3
|
|
Week 13 to Week 24
STARTED
|
1
|
11
|
|
Week 13 to Week 24
COMPLETED
|
1
|
10
|
|
Week 13 to Week 24
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Low Dose Treatment Cohort (LDTC): 0.50 mg/kg Twice Daily (BID)
Patients (pts) received the dose of 0.50 mg/kg BID for 12 weeks in fed condition
|
High Dose Treatment Cohort (HDTC): 0.75 mg/kg BID
Patients received the dose of 0.75 mg/kg BID for 12 weeks in fed conditions
|
|---|---|---|
|
Week 0 to Week 12
Disease Progression
|
1
|
1
|
|
Week 0 to Week 12
Insufficient Response
|
0
|
2
|
|
Week 13 to Week 24
Insufficient Response
|
0
|
1
|
Baseline Characteristics
Efficacy and Safety Dose Finding Study of Givinostat to Treat Polyarticular Course Juvenile Idiopathic Arthritis
Baseline characteristics by cohort
| Measure |
Low Dose Treatment Cohort (LDTC): 0.50 mg/kg BID
n=10 Participants
Patient received the dose of 0.50 mg/kg for 12 weeks in fed condition
|
High Dose Treatment Cohort (HDTC): 0.75 mg/kg BID
n=6 Participants
Patient received the dose of 0.75 mg/kg for 12 weeks in fed condition
|
Total
n=16 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
11.7 years
STANDARD_DEVIATION 5.5 • n=5 Participants
|
9.7 years
STANDARD_DEVIATION 5.7 • n=7 Participants
|
10.9 years
STANDARD_DEVIATION 5.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
10 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Serbia
|
5 participants
n=5 Participants
|
1 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
Czech Republic
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Slovenia
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
2 participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Body Weight
|
37.36 kg
STANDARD_DEVIATION 15.40 • n=5 Participants
|
37.92 kg
STANDARD_DEVIATION 18.59 • n=7 Participants
|
37.57 kg
STANDARD_DEVIATION 16.05 • n=5 Participants
|
|
Height
|
1.388 m
STANDARD_DEVIATION 0.204 • n=5 Participants
|
1.365 m
STANDARD_DEVIATION 0.277 • n=7 Participants
|
1.379 m
STANDARD_DEVIATION 0.225 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks of treatmentACR Pediatric variables include: Physician's Global Assessment of disease activity on a 0-100 mm visual analogue scale from 0 mm = no disease activity to 100 mm = very severe disease activity; Parent's or patient's Global Assessment of Patient's overall well-being on a 100 mm VAS from 0 mm = very well to 100 mm = very poor; Functional ability: Childhood Health Assessment Questionnaire; Number of joints with active arthritis using the ACR definition (any joint with swelling, or in the absence of swelling, limitation of motion accompanied by pain/tenderness not due to bone deformity); Number of joints with limitation of motion; Laboratory measure of inflammation: C-reactive protein (mg/L) Patients were considered as responders if they achieve at least an ACR Pediatric Criteria level 30 of response, defined as a 30% improvement as compared to baseline in at least 3 of the 6 variables listed above, with no more than 1 variable worsening by \> than 30%
Outcome measures
| Measure |
Low Dose Discontinued
n=1 Participants
The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
|
Low Dose Throughout
n=1 Participants
The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
|
Switched Dose
n=8 Participants
The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator's decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort).
|
High Dose Throughout
n=2 Participants
The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
|
High Dose Discontinued
n=4 Participants
The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
|
|---|---|---|---|---|---|
|
ACR Pediatric Response Level (ACRPRL) 30 After 12 Weeks of Treatment
ACR Pediatric Response Level 30
|
0 participants
|
1 participants
|
3 participants
|
2 participants
|
1 participants
|
|
ACR Pediatric Response Level (ACRPRL) 30 After 12 Weeks of Treatment
No response
|
1 participants
|
0 participants
|
5 participants
|
0 participants
|
3 participants
|
SECONDARY outcome
Timeframe: at week12ACR Pediatric variables include: Physician's Global Assessment of disease activity on a 0- 100 mm visual analogue scale from 0 mm = no disease activity to 100 mm = very severe disease activity; Parent's or patient's Global Assessment of Patient's overall well-being on a 100 mm VAS from 0 mm = very well to 100 mm = very poor; Functional ability: Childhood Health Assessment Questionnaire; Number of joints with active arthritis using the ACR definition (any joint with swelling, or in the absence of swelling, limitation of motion accompanied by pain/tenderness not due to bone deformity); Number of joints with limitation of motion; Laboratory measure of inflammation: C-reactive protein (mg/L) Patients were considered as responders if they achieve at least an ACR Pediatric Criteria level 50, 70, 90 and 100 of response, defined as a 50%, 70%, 90% and 100% improvement as compared to baseline in at least 3 of the 6 variables listed above, with no more than 1 variable worsening by \> than 30%
Outcome measures
| Measure |
Low Dose Discontinued
n=1 Participants
The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
|
Low Dose Throughout
n=1 Participants
The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
|
Switched Dose
n=8 Participants
The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator's decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort).
|
High Dose Throughout
n=2 Participants
The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
|
High Dose Discontinued
n=4 Participants
The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
|
|---|---|---|---|---|---|
|
ACR Pediatric Response Level (ACR 50, 70, 90 and 100) at Week 12
ACR Pediatric response Level 50
|
0 participants
|
1 participants
|
1 participants
|
2 participants
|
1 participants
|
|
ACR Pediatric Response Level (ACR 50, 70, 90 and 100) at Week 12
ACR Pediatric response Level 70
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
|
ACR Pediatric Response Level (ACR 50, 70, 90 and 100) at Week 12
ACR Pediatric response Level 90
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
|
ACR Pediatric Response Level (ACR 50, 70, 90 and 100) at Week 12
ACR Pediatric response Level 100
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Low Dose Discontinued
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Low Dose Throughout
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Switched Dose
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
High Dose Throughout
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
High Dose Discontinued
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Low Dose Discontinued
n=1 participants at risk
The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 pts enrolled to initial Low Dose treatment cohort (LD), 1 pt discontinued the study before wk 12 (Low Dose Discontinued treatment cohort).
|
Low Dose Throughout
n=1 participants at risk
The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, one of them continued the same dose for further 12 weeks (Low Dose Throughout treatment cohort)
|
Switched Dose
n=8 participants at risk
The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Of the 10 patients enrolled to initial Low Dose treatment cohort, 4 pts achieved ACR Pediatric Criteria level 30 of response at Week 12, 3 of them switched to the high dose at the Investigator's decision for further 12 weeks agreed by the Sponsor (Switched Dose treatment cohort). Safety data selected for high and low dose in this cohort are not available, this kind of analysis has not been performed.
|
High Dose Throughout
n=2 participants at risk
The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; two patients continued the same dose throughout the study (High Dose Throughout treatment cohort)
|
High Dose Discontinued
n=4 participants at risk
The initial two treatment cohorts were expanded in to 5 treatment cohorts for better evaluation of efficacy and safety end points. Six patients were enrolled to initial High Dose treatment cohort; four patients discontinued the study (High Dose Discontinued treatment cohort
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Blood and lymphatic system disorders
Erythopenia
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Cardiac disorders
Sinus Tachycardia
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Eye disorders
Ocular Hyperaemia
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
25.0%
2/8 • Number of events 2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
100.0%
1/1 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Gastrointestinal disorders
Diarrhoea
|
100.0%
1/1 • Number of events 2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/8 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
25.0%
1/4 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Gastrointestinal disorders
Dry Mouth
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Gastrointestinal disorders
Frequent Bowel Movements
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/8 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
50.0%
1/2 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
37.5%
3/8 • Number of events 3 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
25.0%
1/4 • Number of events 2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
50.0%
1/2 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
25.0%
1/4 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
General disorders
Chills
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
General disorders
Gait Disturbance
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
General disorders
Pyrexia
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
25.0%
1/4 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Infections and infestations
Coxsackie Viral Infection
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/8 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
25.0%
1/4 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Infections and infestations
Influenza
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
25.0%
2/8 • Number of events 3 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Infections and infestations
Otitis Media
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
100.0%
1/1 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/8 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
25.0%
1/4 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Infections and infestations
Pharyngitis Streptococcal
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/8 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
25.0%
1/4 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Infections and infestations
Pharyngotonsillitis
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
50.0%
1/2 • Number of events 2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
100.0%
1/1 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/8 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Infections and infestations
Viral Infection
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Injury, poisoning and procedural complications
Joint Dislocation
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Investigations
Blood Phosphorus Decreased
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
25.0%
2/8 • Number of events 2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Stiffness
|
100.0%
1/1 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/8 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin Papilloma
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Nervous system disorders
Headache
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
50.0%
2/4 • Number of events 2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Reproductive system and breast disorders
Menstruation Irregular
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/8 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
25.0%
1/4 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
25.0%
2/8 • Number of events 2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/8 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
50.0%
1/2 • Number of events 2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
100.0%
1/1 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/8 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
25.0%
1/4 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Skin and subcutaneous tissue disorders
Rash Papular
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
12.5%
1/8 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Skin and subcutaneous tissue disorders
Skin Hyperpigmentation
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/8 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
50.0%
1/2 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/4 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
|
Skin and subcutaneous tissue disorders
Skin Lesion
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/8 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
0.00%
0/2 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
25.0%
1/4 • Number of events 1 • Planned treatment duration was 24 weeks overall (12 weeks + 12 weeks). The mean (SD) duration of treatment was 131.9 (55.9) days overall, with a median duration of 170 days.
All 16 pts experienced TEAEs; a total of 71 events: 5 (31.3%) pts experienced a total of 7 TEAEs considered related to the IMP. The severe TEAE experienced by 1 (6.3%) pt led to study discontinuation. No serious TEAEs or TEAEs with fatal outcome were reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60