Trial Outcomes & Findings for Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients (PLEO-CMT) (NCT NCT02579759)
NCT ID: NCT02579759
Last Updated: 2020-02-27
Results Overview
The primary efficacy variable used in the main analysis is the mean of the available ONLS values at month 12 and month 15. The ONLS is a disability scale that was derived and improved from the Overall Disability Sum Score (ODSS) to measure limitations in the everyday activities of the upper limbs (rated on 5 points) and the lower limbs (rated on 7 points). The total score is a 12-point scale: 0 (no disability) to 12 (maximum disability). Lower values in the ONLS indicate a better clinical condition. Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
323 participants
Primary outcome timeframe
From Baseline to Month 15
Results posted on
2020-02-27
Participant Flow
Participant milestones
| Measure |
PXT3003 Dose 1
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Overall Study
STARTED
|
109
|
113
|
101
|
|
Overall Study
COMPLETED
|
85
|
49
|
80
|
|
Overall Study
NOT COMPLETED
|
24
|
64
|
21
|
Reasons for withdrawal
| Measure |
PXT3003 Dose 1
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
2
|
0
|
0
|
|
Overall Study
Other (Sponsor stopped Dose 2)
|
0
|
1
|
0
|
|
Overall Study
BfArM hold
|
13
|
12
|
12
|
|
Overall Study
Sponsor stopped Dose 2
|
0
|
41
|
0
|
|
Overall Study
Non compliance
|
0
|
1
|
0
|
|
Overall Study
Pregnancy
|
0
|
1
|
0
|
|
Overall Study
Inclusion/exclusion criteria
|
0
|
0
|
1
|
|
Overall Study
Adverse Event
|
4
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
3
|
5
|
|
Overall Study
Lost to Follow-up
|
2
|
2
|
2
|
Baseline Characteristics
Phase III Trial Assessing the Efficacy and Safety of PXT3003 in CMT1A Patients (PLEO-CMT)
Baseline characteristics by cohort
| Measure |
PXT3003 Dose 1
n=109 Participants
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months
PXT3003 dose 1: Liquid oral solution, 5 ml twice a day, morning and evening with food
|
PXT3003 Dose 2
n=113 Participants
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months
PXT3003 dose 2: Liquid oral solution, 5 ml twice a day, morning and evening with food
|
Placebo
n=101 Participants
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months
placebo: Liquid oral solution, 5 ml twice a day, morning and evening with food
|
Total
n=323 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
5 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
15 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
103 Participants
n=99 Participants
|
104 Participants
n=107 Participants
|
97 Participants
n=206 Participants
|
304 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Age, Continuous
|
41.0 years
STANDARD_DEVIATION 12.3 • n=99 Participants
|
39.6 years
STANDARD_DEVIATION 13.9 • n=107 Participants
|
42.1 years
STANDARD_DEVIATION 13.2 • n=206 Participants
|
40.9 years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
|
Sex: Female, Male
Female
|
60 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
62 Participants
n=206 Participants
|
190 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
49 Participants
n=99 Participants
|
45 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
133 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
108 Participants
n=99 Participants
|
111 Participants
n=107 Participants
|
100 Participants
n=206 Participants
|
319 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Region of Enrollment
Canada
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
5 participants
n=206 Participants
|
14 participants
n=7 Participants
|
|
Region of Enrollment
Netherlands
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
3 participants
n=206 Participants
|
8 participants
n=7 Participants
|
|
Region of Enrollment
Belgium
|
4 participants
n=99 Participants
|
6 participants
n=107 Participants
|
5 participants
n=206 Participants
|
15 participants
n=7 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=99 Participants
|
24 participants
n=107 Participants
|
18 participants
n=206 Participants
|
63 participants
n=7 Participants
|
|
Region of Enrollment
United Kingdom
|
2 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
3 participants
n=7 Participants
|
|
Region of Enrollment
France
|
31 participants
n=99 Participants
|
31 participants
n=107 Participants
|
29 participants
n=206 Participants
|
91 participants
n=7 Participants
|
|
Region of Enrollment
Germany
|
22 participants
n=99 Participants
|
23 participants
n=107 Participants
|
22 participants
n=206 Participants
|
67 participants
n=7 Participants
|
|
Region of Enrollment
Spain
|
22 participants
n=99 Participants
|
22 participants
n=107 Participants
|
18 participants
n=206 Participants
|
62 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: From Baseline to Month 15Population: mFAS selection
The primary efficacy variable used in the main analysis is the mean of the available ONLS values at month 12 and month 15. The ONLS is a disability scale that was derived and improved from the Overall Disability Sum Score (ODSS) to measure limitations in the everyday activities of the upper limbs (rated on 5 points) and the lower limbs (rated on 7 points). The total score is a 12-point scale: 0 (no disability) to 12 (maximum disability). Lower values in the ONLS indicate a better clinical condition. Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin).
Outcome measures
| Measure |
PXT3003 Dose 1
n=93 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
n=55 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
n=87 Participants
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Overall Neuropathy Limitation Scale (ONLS) Total Score
Base
|
3.33 Scores on the ONLS
Standard Deviation 1.05
|
3.05 Scores on the ONLS
Standard Deviation 1.13
|
3.23 Scores on the ONLS
Standard Deviation 1.19
|
|
Overall Neuropathy Limitation Scale (ONLS) Total Score
Fin
|
3.25 Scores on the ONLS
Standard Deviation 1.00
|
2.82 Scores on the ONLS
Standard Deviation 1.28
|
3.36 Scores on the ONLS
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: From Baseline to Month 15Population: mFAS selection
This outcome measure is the mean of the available 10MWT values at month 12 and month 15. The 10MWT is a simple to administer, standardized, reliable and valid evaluation of functional exercise capacity and gait that has been used to evaluate neurologic disorders and CMT patients. Lower Time to Walk 10 Meters values indicate a better clinical condition. Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin).
Outcome measures
| Measure |
PXT3003 Dose 1
n=93 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
n=55 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
n=87 Participants
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Mean of Ten Meter Walking Test (10MWT)
Base
|
6.93 Seconds (s)
Standard Deviation 1.77
|
7.14 Seconds (s)
Standard Deviation 1.77
|
7.28 Seconds (s)
Standard Deviation 1.91
|
|
Mean of Ten Meter Walking Test (10MWT)
Fin
|
6.47 Seconds (s)
Standard Deviation 1.59
|
6.52 Seconds (s)
Standard Deviation 1.39
|
6.91 Seconds (s)
Standard Deviation 1.82
|
SECONDARY outcome
Timeframe: From Baseline to Month 15Population: mFAS selection
This outcome measure is the mean of the available CMTNS-v2 Sensory Score values at month 12 and month 15. The CMTNS-v2 is a specific scale designed to assess severity of impairment in CMT disease. It is a 36-point scale based on nine items to quantify impairment (sensory symptoms, pin sensibility, vibration and arm and leg strength), activity limitations (motor symptoms arms and legs) and electrophysiological function (amplitudes of ulnar CMAP and SNAP). The CMTNS-v2 goes from 0 (no impairment) to 36 (maximum impairment) whom each sub-items goes from 0 to 4. The CMTNS-v2 Sensory score is summed of items 1+4+5 of CMTNS-v2 (Sensory symptoms, Pinprick sensibility and Vibration). It is a 12-point score: 0 (no impairment) to 12 (maximum impairment). Lower CMTNS-v2 Sensory Score values indicate a better clinical condition. Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin).
Outcome measures
| Measure |
PXT3003 Dose 1
n=93 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
n=55 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
n=87 Participants
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Mean of the CMTNS-v2 Sensory Score
Base
|
5.00 Scores on the CMTNS-v2 Sensory Score
Standard Deviation 2.28
|
4.47 Scores on the CMTNS-v2 Sensory Score
Standard Deviation 2.21
|
4.97 Scores on the CMTNS-v2 Sensory Score
Standard Deviation 2.04
|
|
Mean of the CMTNS-v2 Sensory Score
Fin
|
4.55 Scores on the CMTNS-v2 Sensory Score
Standard Deviation 1.96
|
4.23 Scores on the CMTNS-v2 Sensory Score
Standard Deviation 2.38
|
4.68 Scores on the CMTNS-v2 Sensory Score
Standard Deviation 2.14
|
SECONDARY outcome
Timeframe: From Baseline to Month 15Population: mFAS selection
This outcome measure is the mean of the available CMTNS-v2 Examination Score values at month 12 and month 15. The CMTNS-v2 is a specific scale designed to assess severity of impairment in CMT disease. It is a 36-point scale based on nine items to quantify impairment (sensory symptoms, pin sensibility, vibration and arm and leg strength), activity limitations (motor symptoms arms and legs) and electrophysiological function (amplitudes of ulnar CMAP and SNAP). The CMTNS-v2 goes from 0 (no impairment) to 36 (maximum impairment) whom each sub-items goes from 0 to 4. The CMTES-v2 is summed of item 1 to 7 of the CMTNS-v2 (limited to impairment items and excluding electrophysiological items). It is a 28-point score: 0 (no impairment) to 28 (maximum impairment). Lower CMTES-v2 values indicate a better clinical condition. Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin).
Outcome measures
| Measure |
PXT3003 Dose 1
n=93 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
n=55 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
n=87 Participants
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Mean of the CMTNS-v2 Examination Score (CMTES-v2)
Fin
|
9.01 Scores on the CMTES-v2
Standard Deviation 2.62
|
8.24 Scores on the CMTES-v2
Standard Deviation 3.13
|
9.02 Scores on the CMTES-v2
Standard Deviation 3.05
|
|
Mean of the CMTNS-v2 Examination Score (CMTES-v2)
Base
|
9.49 Scores on the CMTES-v2
Standard Deviation 2.80
|
8.78 Scores on the CMTES-v2
Standard Deviation 2.73
|
9.51 Scores on the CMTES-v2
Standard Deviation 2.79
|
SECONDARY outcome
Timeframe: From Baseline to Month 15Population: mFAS selection
This outcome measure is the mean of the available 9-HPT values at month 12 and month 15. The Nine-Hole Peg Test (9HPT) is a simple timed test of fine motor coordination of extremitied in the upper limbs. It measures the time needed by the patient to insert 9 pegs in nine holes and to remove them (normal required time 18 seconds). Lower 9HPT values indicate a better clinical condition. Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin).
Outcome measures
| Measure |
PXT3003 Dose 1
n=93 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
n=55 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
n=87 Participants
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Mean of the Results at the Nine-Hole Peg Test (9-HPT)
Base
|
25.62 Seconds (s)
Standard Deviation 5.60
|
27.33 Seconds (s)
Standard Deviation 11.15
|
25.18 Seconds (s)
Standard Deviation 4.41
|
|
Mean of the Results at the Nine-Hole Peg Test (9-HPT)
Fin
|
23.85 Seconds (s)
Standard Deviation 4.52
|
25.67 Seconds (s)
Standard Deviation 8.29
|
24.41 Seconds (s)
Standard Deviation 4.01
|
SECONDARY outcome
Timeframe: The period between the patient signing the informed consent and 30 days after the end of study (i.e. completion/early discontinuation/last contact as recorded on the 'Study Completion on Early Termination' form up to 15 months)Population: FAS selection
Safety selection was to include all randomized patients that have received at least one dose of study treatment. Safety and tolerability of PXT3003 were compared to placebo on the incidence of treatment-emergent adverse events (TEAEs); they were evaluated by type/nature, severity/intensity, seriousness, and relationship to study drug.
Outcome measures
| Measure |
PXT3003 Dose 1
n=109 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
n=113 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
n=101 Participants
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Number of Subjects With at Least One TEAE
Any TEAE
|
89 participants
|
87 participants
|
83 participants
|
|
Number of Subjects With at Least One TEAE
Any related TEAE
|
39 participants
|
38 participants
|
34 participants
|
|
Number of Subjects With at Least One TEAE
Any moderately severe or severe related TEAE
|
8 participants
|
5 participants
|
10 participants
|
SECONDARY outcome
Timeframe: The period between the patient signing the informed consent and 30 days after the end of study (i.e. completion/early discontinuation/last contact as recorded on the 'Study Completion on Early Termination' form up to 15 months)Population: FAS selection
Safety and tolerability of PXT3003 were compared to placebo on the incidence of TEAEs leading to withdrawal of study drug.
Outcome measures
| Measure |
PXT3003 Dose 1
n=109 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
n=113 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
n=101 Participants
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Incidence of AE Leading to Withdrawal of Study Drug
Any TEAE leading to drug withdrawal
|
6 participants
|
6 participants
|
6 participants
|
|
Incidence of AE Leading to Withdrawal of Study Drug
Any related TEAE leading to drug withdrawal
|
3 participants
|
2 participants
|
2 participants
|
SECONDARY outcome
Timeframe: The period between the patient signing the informed consent and 30 days after the end of study (i.e. completion/early discontinuation/last contact as recorded on the 'Study Completion on Early Termination' form up to 15 months).Population: FAS selection
Safety and tolerability of PXT3003 were compared to placebo on the incidence of serious adverse events (SAEs).
Outcome measures
| Measure |
PXT3003 Dose 1
n=109 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
n=113 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
n=101 Participants
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Incidence of SAEs
Any serious TEAE
|
10 participants
|
3 participants
|
5 participants
|
|
Incidence of SAEs
Any related serious TEAE
|
0 participants
|
0 participants
|
0 participants
|
|
Incidence of SAEs
Any serious TEAE leading to drug withdrawal
|
1 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline to Month 15Population: mFAS selection
This outcome measure is the mean of the available CMTNS-v2 Sensory Symptoms values at month 12 and month 15. The CMTNS-v2 is a specific scale designed to assess severity of impairment in CMT disease. It is a 36-point scale based on nine items to quantify impairment (sensory symptoms, pin sensibility, vibration and arm and leg strength), activity limitations (motor symptoms arms and legs) and electrophysiological function (amplitudes of ulnar CMAP and SNAP). The CMTNS-v2 goes from 0 (no impairment) to 36 (maximum impairment) whom each sub-items goes from 0 to 4. The CMTNS-v2 Sensory Symptoms is the first item of the CMTNS-v2. It is a 4-point score: 0 (no impairment) to 4 (maximum impairment). Lower CMTNS-v2 Sensory Symptoms values indicate a better clinical condition. Reported values are the values at Baseline (Base) and the average of the available values at Month 12 and Month 15 (Fin).
Outcome measures
| Measure |
PXT3003 Dose 1
n=93 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
n=55 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
n=87 Participants
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Mean of the CMTNS-v2 Sensory Symptoms
Base
|
1.26 Scores on the CMTNS-v2 Sensory Symptoms
Standard Deviation 0.95
|
0.96 Scores on the CMTNS-v2 Sensory Symptoms
Standard Deviation 0.98
|
1.09 Scores on the CMTNS-v2 Sensory Symptoms
Standard Deviation 0.90
|
|
Mean of the CMTNS-v2 Sensory Symptoms
Fin
|
1.18 Scores on the CMTNS-v2 Sensory Symptoms
Standard Deviation 0.81
|
0.93 Scores on the CMTNS-v2 Sensory Symptoms
Standard Deviation 0.96
|
1.21 Scores on the CMTNS-v2 Sensory Symptoms
Standard Deviation 0.94
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Month 12 and Month 15Population: PP selection LLOQ = 30 pg/mL The placebo arm has not been described for this endpoint.
Plasma concentration of PXT3003 components were measured at trough (prior to dose) and 90 minutes after drug intake. The mean plasma values of the baseline correspond to half of the administered dose.
Outcome measures
| Measure |
PXT3003 Dose 1
n=68 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
n=38 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Plasma Concentrations of Baclofen at Trough and at 90 Min After Drug Intake
At trough, at Month 12
|
13739.3 pg/mL
Standard Deviation 20313.6
|
11651.9 pg/mL
Standard Deviation 6151.1
|
—
|
|
Plasma Concentrations of Baclofen at Trough and at 90 Min After Drug Intake
At trough, at Month 15
|
9009.7 pg/mL
Standard Deviation 10910.3
|
8686.6 pg/mL
Standard Deviation 9172.8
|
—
|
|
Plasma Concentrations of Baclofen at Trough and at 90 Min After Drug Intake
At 90 min after drug intake, at Month 12
|
52201.6 pg/mL
Standard Deviation 21494.6
|
90238.7 pg/mL
Standard Deviation 29972.8
|
—
|
|
Plasma Concentrations of Baclofen at Trough and at 90 Min After Drug Intake
At 90 min after drug intake, at Month 15
|
47021.1 pg/mL
Standard Deviation 19834.5
|
105825.4 pg/mL
Standard Deviation 38756.7
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Month 12 and month 15Population: PP selection LLOQ = 30 pg/mL The placebo arm has not been described for this endpoint.
Plasma concentration of PXT3003 components were measured at trough (prior to dose) and 90 minutes after drug intake. The mean plasma values of the baseline correspond to half of the administered dose.
Outcome measures
| Measure |
PXT3003 Dose 1
n=68 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
n=38 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Plasma Concentrations of Naltrexone at Trough and at 90 Min After Drug Intake
At trough, at Month 15
|
31.8 pg/mL
Standard Deviation 14.0
|
30.0 pg/mL
Standard Deviation 0.0
|
—
|
|
Plasma Concentrations of Naltrexone at Trough and at 90 Min After Drug Intake
At trough, at Month 12
|
33.0 pg/mL
Standard Deviation 15.8
|
42.0 pg/mL
Standard Deviation 66.0
|
—
|
|
Plasma Concentrations of Naltrexone at Trough and at 90 Min After Drug Intake
At 90 min after drug intake, at Month 12
|
63.0 pg/mL
Standard Deviation 47.4
|
107.5 pg/mL
Standard Deviation 88.6
|
—
|
|
Plasma Concentrations of Naltrexone at Trough and at 90 Min After Drug Intake
At 90 min after drug intake, at Month 15
|
55.0 pg/mL
Standard Deviation 39.3
|
130.9 pg/mL
Standard Deviation 81.4
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: At Month 12 and Month 15Population: PP selection LLOQ = 50 pg/mL The placebo arm has not been described for this endpoint.
Plasma concentration of PXT3003 components were measured at trough (prior to dose) and peak (90 minutes post dose). The mean plasma values of the baseline correspond to half of the administered dose.
Outcome measures
| Measure |
PXT3003 Dose 1
n=68 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
n=38 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Plasma Concentrations of 6β-naltrexol at Trough and at 90 Min After Drug Intake
At 90 min after drug intake, at Month 15
|
586.4 pg/mL
Standard Deviation 205.4
|
1450.9 pg/mL
Standard Deviation 438.0
|
—
|
|
Plasma Concentrations of 6β-naltrexol at Trough and at 90 Min After Drug Intake
At trough, at Month 12
|
290.1 pg/mL
Standard Deviation 177.4
|
526.4 pg/mL
Standard Deviation 245.6
|
—
|
|
Plasma Concentrations of 6β-naltrexol at Trough and at 90 Min After Drug Intake
At trough, at Month 15
|
260.4 pg/mL
Standard Deviation 121.8
|
352.3 pg/mL
Standard Deviation 319.0
|
—
|
|
Plasma Concentrations of 6β-naltrexol at Trough and at 90 Min After Drug Intake
At 90 min after drug intake, at Month 12
|
632.5 pg/mL
Standard Deviation 230.1
|
1257.1 pg/mL
Standard Deviation 454.3
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline to Month 15Population: Completers selection
ONLS Therapy Response 1 was defined as the number of participants (responders) with an improvement on final ONLS Total Score of at least one point. A higher response rate indicate a better clinical condition.
Outcome measures
| Measure |
PXT3003 Dose 1
n=85 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
n=49 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
n=80 Participants
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Number of Participants With ONLS Therapy Response 1
|
16 Number of Participants
|
14 Number of Participants
|
14 Number of Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From Baseline to Month 15Population: Completers selection
ONLS Therapy Response 2 was defined as the number of participants with no deterioration (responders) on final ONLS Total Score. A higher response rate indicates a better clinical condition.
Outcome measures
| Measure |
PXT3003 Dose 1
n=85 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
n=89 Participants
Liquid oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
n=80 Participants
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Number of Participants With ONLS Therapy Response 2
|
66 Number of Participants
|
42 Number of Participants
|
58 Number of Participants
|
Adverse Events
PXT3003 Dose 1
Serious events: 10 serious events
Other events: 89 other events
Deaths: 0 deaths
PXT3003 Dose 2
Serious events: 3 serious events
Other events: 87 other events
Deaths: 0 deaths
Placebo
Serious events: 5 serious events
Other events: 83 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
PXT3003 Dose 1
n=109 participants at risk
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
n=113 participants at risk
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
n=101 participants at risk
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Surgical and medical procedures
Arthrolysis
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.99%
1/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.92%
1/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.92%
1/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.92%
1/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Psychiatric disorders
Suicide attempt
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.99%
1/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Reproductive system and breast disorders
Endometriosis
|
0.92%
1/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Injury, poisoning and procedural complications
Clavicle fracture
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.99%
1/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.92%
1/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.99%
1/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Injury, poisoning and procedural complications
Injury
|
0.92%
1/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Injury, poisoning and procedural complications
Median nerve injury
|
0.92%
1/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.92%
1/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.99%
1/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Cardiac disorders
Palpitations
|
0.92%
1/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Congenital, familial and genetic disorders
Congenital foot malformation
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.99%
1/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Congenital, familial and genetic disorders
Patent ductus arteriosus
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.88%
1/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
0.92%
1/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.99%
1/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Nervous system disorders
Seizure
|
0.92%
1/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Gastrointestinal disorders
Proctitis
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.88%
1/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.92%
1/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Renal and urinary disorders
Hydronephrosis
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.88%
1/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Renal and urinary disorders
Ureterolithiasis
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.88%
1/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Musculoskeletal and connective tissue disorders
Chest wall haematoma
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.99%
1/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Infections and infestations
Appendicitis
|
0.92%
1/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.88%
1/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
Other adverse events
| Measure |
PXT3003 Dose 1
n=109 participants at risk
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 1: 3 mg baclofen, 0.35 mg naltrexone and 105 mg sorbitol (twice a day, morning and evening with food).
|
PXT3003 Dose 2
n=113 participants at risk
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 dose 2: 6 mg baclofen, 0.70 mg naltrexone and 210 sorbitol (twice a day, morning and evening with food).
|
Placebo
n=101 participants at risk
Oral solution, 5 ml b.i.d. (taken morning and evening with food) during 15 months.
PXT3003 matching placebo had the same presentation, the same aspect and taste in order to be undistinguishable (twice a day, morning and evening with food).
|
|---|---|---|---|
|
Vascular disorders
Hypotension
|
0.92%
1/109 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.88%
1/113 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
General disorders
Asthenia
|
2.8%
3/109 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
1.8%
2/113 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
6.9%
7/101 • Number of events 9 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
General disorders
Fatigue
|
10.1%
11/109 • Number of events 15 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
1.8%
2/113 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
5.9%
6/101 • Number of events 6 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
General disorders
Influenza like illness
|
2.8%
3/109 • Number of events 5 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
5.3%
6/113 • Number of events 9 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
General disorders
Peripheral swelling
|
0.92%
1/109 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Psychiatric disorders
Anxiety
|
2.8%
3/109 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
1.8%
2/113 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Psychiatric disorders
Depression
|
0.92%
1/109 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
5.0%
5/101 • Number of events 5 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Psychiatric disorders
Insomnia
|
0.92%
1/109 • Number of events 4 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.88%
1/113 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
3.0%
3/101 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Psychiatric disorders
Sleep disorder
|
0.92%
1/109 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
1.8%
2/113 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.92%
1/109 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.88%
1/113 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
3.0%
3/101 • Number of events 4 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Injury, poisoning and procedural complications
Fall
|
8.3%
9/109 • Number of events 15 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.7%
3/113 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
6.9%
7/101 • Number of events 9 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Injury, poisoning and procedural complications
Laceration
|
2.8%
3/109 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
7.3%
8/109 • Number of events 9 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
1.8%
2/113 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
8.9%
9/101 • Number of events 12 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.92%
1/109 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.88%
1/113 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Investigations
Weight increased
|
0.92%
1/109 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
5.0%
5/101 • Number of events 6 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Cardiac disorders
Palpitations
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.88%
1/113 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.8%
3/109 • Number of events 6 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
1.8%
2/113 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
5.0%
5/101 • Number of events 8 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Nervous system disorders
Dizziness
|
8.3%
9/109 • Number of events 10 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
4.4%
5/113 • Number of events 5 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Nervous system disorders
Headache
|
15.6%
17/109 • Number of events 22 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
11.5%
13/113 • Number of events 20 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
10.9%
11/101 • Number of events 14 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Nervous system disorders
Hypoaesthesia
|
0.92%
1/109 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.7%
3/113 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Nervous system disorders
Migraine
|
0.92%
1/109 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.7%
3/113 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Nervous system disorders
Paraesthesia
|
1.8%
2/109 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.7%
3/113 • Number of events 5 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Nervous system disorders
Sciatica
|
0.92%
1/109 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
1.8%
2/113 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Nervous system disorders
Somnolence
|
4.6%
5/109 • Number of events 5 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
1.8%
2/113 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.99%
1/101 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Nervous system disorders
Tremor
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.7%
3/113 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.99%
1/101 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Ear and labyrinth disorders
Tinnitus
|
1.8%
2/109 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.88%
1/113 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Ear and labyrinth disorders
Vertigo
|
2.8%
3/109 • Number of events 4 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.88%
1/113 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Gastrointestinal disorders
Abdominal pain
|
1.8%
2/109 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
4.4%
5/113 • Number of events 5 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
3.0%
3/101 • Number of events 4 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
2.8%
3/109 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
3.5%
4/113 • Number of events 5 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
3.0%
3/101 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Gastrointestinal disorders
Constipation
|
3.7%
4/109 • Number of events 4 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
1.8%
2/113 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.4%
7/109 • Number of events 9 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
6.2%
7/113 • Number of events 8 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
6.9%
7/101 • Number of events 8 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Gastrointestinal disorders
Dry mouth
|
2.8%
3/109 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.7%
3/113 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
4.0%
4/101 • Number of events 4 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.92%
1/109 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
1.8%
2/113 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
3.0%
3/101 • Number of events 4 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Gastrointestinal disorders
Nausea
|
11.0%
12/109 • Number of events 17 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
6.2%
7/113 • Number of events 7 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
5.9%
6/101 • Number of events 6 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Gastrointestinal disorders
Toothache
|
3.7%
4/109 • Number of events 4 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.99%
1/101 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Gastrointestinal disorders
Vomiting
|
1.8%
2/109 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
4.4%
5/113 • Number of events 5 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.99%
1/101 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.92%
1/109 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
1.8%
2/113 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.9%
13/109 • Number of events 19 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.7%
3/113 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
7.9%
8/101 • Number of events 8 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.2%
10/109 • Number of events 12 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
4.4%
5/113 • Number of events 5 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
3.0%
3/101 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Musculoskeletal and connective tissue disorders
Bone callus excessive
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.92%
1/109 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
4.0%
4/101 • Number of events 4 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.6%
5/109 • Number of events 7 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
7.1%
8/113 • Number of events 9 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
5.9%
6/101 • Number of events 6 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.92%
1/109 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
3.5%
4/113 • Number of events 4 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.99%
1/101 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.8%
3/109 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.88%
1/113 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
2.8%
3/109 • Number of events 4 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.7%
3/113 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
3.0%
3/101 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
2.8%
3/109 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
1.8%
2/113 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/101 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.2%
10/109 • Number of events 13 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
4.4%
5/113 • Number of events 6 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
8.9%
9/101 • Number of events 13 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
3.0%
3/101 • Number of events 4 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
1.8%
2/109 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.7%
3/113 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
4.0%
4/101 • Number of events 4 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.7%
3/113 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.99%
1/101 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.88%
1/113 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
3.0%
3/101 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Infections and infestations
Bronchitis
|
1.8%
2/109 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.88%
1/113 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
5.9%
6/101 • Number of events 6 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Infections and infestations
Cystitis
|
1.8%
2/109 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Infections and infestations
Gastroenteritis
|
2.8%
3/109 • Number of events 4 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.7%
3/113 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
5.0%
5/101 • Number of events 5 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Infections and infestations
Influenza
|
2.8%
3/109 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
5.3%
6/113 • Number of events 6 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
3.0%
3/101 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Infections and infestations
Nasopharyngitis
|
22.0%
24/109 • Number of events 31 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
15.9%
18/113 • Number of events 26 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
14.9%
15/101 • Number of events 24 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Infections and infestations
Pharyngitis
|
1.8%
2/109 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Infections and infestations
Respiratory tract infection
|
0.92%
1/109 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Infections and infestations
Rhinitis
|
2.8%
3/109 • Number of events 3 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.7%
3/113 • Number of events 4 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
4.0%
4/101 • Number of events 5 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Infections and infestations
Sinusitis
|
6.4%
7/109 • Number of events 8 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
5.3%
6/113 • Number of events 6 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.99%
1/101 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Infections and infestations
Tracheitis
|
0.00%
0/109 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.00%
0/113 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Infections and infestations
Upper respiratory tract infection
|
1.8%
2/109 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
0.88%
1/113 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
|
Infections and infestations
Urinary tract infection
|
0.92%
1/109 • Number of events 1 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.7%
3/113 • Number of events 5 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
2.0%
2/101 • Number of events 2 • The AE reporting period therefore started with the subject signing the informed consent form and ended 30 days after the end of study (corresponding to the date of "Date of completion/early discontinuation/last contact" recorded in the termination module up to 15 months)
This definition was extended due to the discontinuation of Dose 2 and study on hold in Germany. The period of AE reporting was extended to 1 month after the end of study, without informed consent signed for study CLN-PXT3003-03 during this period. Only Treatment-Emergent Adverse Events (TEAE) have been reported for non-serious advers events.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place