Trial Outcomes & Findings for An Open-label Extension Trial of Cannabidiol (GWP42003-P, CBD) for Seizures in Tuberous Sclerosis Complex (GWPCARE6) (NCT NCT02544750)
NCT ID: NCT02544750
Last Updated: 2022-07-14
Results Overview
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. An AE that started, or worsened in severity or seriousness, following the first dose of IMP was considered a TEAE. A serious AE was defined as any AE that results in any of the following outcomes: death, life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or cancer, any other experience that suggests a significant hazard, contraindication, side effect or precaution that may require medical or surgical intervention to prevent one of the outcomes listed above, or an event that changes the risk/benefit ratio of the study.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
199 participants
Primary outcome timeframe
OLE Day 1 up to 4 years
Results posted on
2022-07-14
Participant Flow
A total of 199 participants with tuberous sclerosis complex (TSC) who met all inclusion criteria and no exclusion criteria and completed the double-blind study GWEP1521 (NCT02544763) were enrolled into this Open-label Extension (OLE) study to receive GWP42003-P.
OLE investigational medicinal product (IMP) was titrated up to 25 mg/kg/day while blinded IMP was simultaneously tapered down to zero to accommodate those participants who had been randomized to placebo during the double-blind phase (DBP) of the study. All participants were to complete the transition and enter the OLE taking 25 mg/kg/day GWP42003-P.
Participant milestones
| Measure |
GWP42003-P (Double-blind Phase)
Participants who had received GWP42003-P during the double-blind phase and then GWP42003-P in the OLE phase.
|
Placebo (Double-blind Phase)
Participants who had received placebo during the double-blind phase and then GWP42003-P in the OLE phase.
|
|---|---|---|
|
Overall Study
STARTED
|
124
|
75
|
|
Overall Study
COMPLETED
|
22
|
12
|
|
Overall Study
NOT COMPLETED
|
102
|
63
|
Reasons for withdrawal
| Measure |
GWP42003-P (Double-blind Phase)
Participants who had received GWP42003-P during the double-blind phase and then GWP42003-P in the OLE phase.
|
Placebo (Double-blind Phase)
Participants who had received placebo during the double-blind phase and then GWP42003-P in the OLE phase.
|
|---|---|---|
|
Overall Study
Physician Decision
|
3
|
1
|
|
Overall Study
Other reasons
|
69
|
39
|
|
Overall Study
Met withdrawal criteria
|
2
|
2
|
|
Overall Study
Transition To Commercial Product
|
1
|
0
|
|
Overall Study
Withdrawal by Parent/Guardian
|
8
|
7
|
|
Overall Study
Adverse Event
|
8
|
10
|
|
Overall Study
Withdrawal by Subject
|
10
|
4
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
Baseline Characteristics
Seizure frequency was assessed in the OLE Safety Analysis Set.
Baseline characteristics by cohort
| Measure |
GWP42003-P (Double-blind Phase)
n=124 Participants
Participants who had received GWP42003-P during the double-blind phase and then GWP42003-P in the OLE phase.
|
Placebo (Double-blind Phase)
n=75 Participants
Participants who had received placebo during the double-blind phase and then GWP42003-P in the OLE phase.
|
Total
n=199 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
12.69 years
STANDARD_DEVIATION 9.64 • n=5 Participants
|
13.92 years
STANDARD_DEVIATION 10.63 • n=7 Participants
|
13.15 years
STANDARD_DEVIATION 10.02 • n=5 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
118 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
111 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
7 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Baseline Tuberous Sclerosis Complex (TSC)-Associated Seizures
|
58.08 Seizures
n=5 Participants • Seizure frequency was assessed in the OLE Safety Analysis Set.
|
55.10 Seizures
n=7 Participants • Seizure frequency was assessed in the OLE Safety Analysis Set.
|
56.90 Seizures
n=5 Participants • Seizure frequency was assessed in the OLE Safety Analysis Set.
|
|
Baseline Total Seizures
|
59.95 Seizures
n=5 Participants • OLE Safety Analysis Set
|
56.97 Seizures
n=7 Participants • OLE Safety Analysis Set
|
58.90 Seizures
n=5 Participants • OLE Safety Analysis Set
|
PRIMARY outcome
Timeframe: OLE Day 1 up to 4 yearsPopulation: Adverse events were assessed in the OLE Safety Analysis Set.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. An AE that started, or worsened in severity or seriousness, following the first dose of IMP was considered a TEAE. A serious AE was defined as any AE that results in any of the following outcomes: death, life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or cancer, any other experience that suggests a significant hazard, contraindication, side effect or precaution that may require medical or surgical intervention to prevent one of the outcomes listed above, or an event that changes the risk/benefit ratio of the study.
Outcome measures
| Measure |
GWP42003-P (Double-blind Phase)
n=124 Participants
Participants who had received GWP42003-P during the double-blind phase and then GWP42003-P in the OLE phase.
|
Placebo (Double-blind Phase)
n=75 Participants
Participants who had received placebo during double-blind phase and then GWP42003-P in the OLE phase.
|
|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE)
Any TEAE
|
117 Participants
|
75 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE)
Any treatment-related TEAE
|
80 Participants
|
60 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE)
Any TEAE leading to permanent discontinuation of IMP
|
11 Participants
|
7 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE)
Any treatment-related TEAE leading to permanent discontinuation of IMP
|
9 Participants
|
7 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE)
Any serious TEAE
|
38 Participants
|
18 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE)
Any treatment-related serious TEAE
|
7 Participants
|
8 Participants
|
|
Number of Participants With Any Treatment-emergent Adverse Events, Discontinuations Due to AEs, Serious AEs, and Treatment-related AEs (TEAE)
Any fatal TEAEs
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: OLE Day 1 up to 4 yearsPopulation: Adverse events were assessed in the OLE Safety Analysis Set.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. An AE that started, or worsened in severity or seriousness, following the first dose of IMP was considered a TEAE. Grade 1 (Mild) is defined as asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated. Grade 2 (Moderate) is defined as minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental activities of daily living (ADL). Grade 3 (Severe) is defined as medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL.
Outcome measures
| Measure |
GWP42003-P (Double-blind Phase)
n=124 Participants
Participants who had received GWP42003-P during the double-blind phase and then GWP42003-P in the OLE phase.
|
Placebo (Double-blind Phase)
n=75 Participants
Participants who had received placebo during double-blind phase and then GWP42003-P in the OLE phase.
|
|---|---|---|
|
Number of Participants With Any TEAE, by Severity
Mild TEAE
|
35 Participants
|
16 Participants
|
|
Number of Participants With Any TEAE, by Severity
Moderate TEAE
|
63 Participants
|
48 Participants
|
|
Number of Participants With Any TEAE, by Severity
Severe TEAE
|
19 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: OLE Day 1 up to 4 yearsPopulation: TSC-associated seizures were assessed in the OLE Safety Analysis Set.
TSC-associated seizures include: focal motor seizures without impairment of consciousness or awareness; focal seizures with impairment of consciousness or awareness; focal seizures evolving to bilateral generalized convulsive seizures and tonic-clonic, tonic, clonic or atonic seizures. A negative percent change from baseline indicates improvement.
Outcome measures
| Measure |
GWP42003-P (Double-blind Phase)
n=124 Participants
Participants who had received GWP42003-P during the double-blind phase and then GWP42003-P in the OLE phase.
|
Placebo (Double-blind Phase)
n=75 Participants
Participants who had received placebo during double-blind phase and then GWP42003-P in the OLE phase.
|
|---|---|---|
|
Percent Change From Baseline in the Number of TSC-associated Seizures During the OLE Treatment Period
|
-55.66 percent change
Interval -86.47 to -12.33
|
-46.76 percent change
Interval -78.17 to -15.69
|
SECONDARY outcome
Timeframe: OLE Day 1 up to 4 yearsPopulation: Treatment responders were assessed in the OLE Safety Analysis Set.
Treatment responders were defined as those participants with a ≥50% reduction from baseline in TSC-associated seizure frequency, during the treatment period, for participants who had not withdrawn from the trial during the treatment period. TSC-associated seizures included: focal motor seizures without impairment of consciousness or awareness (Type 1 focal motor); focal seizures with impairment of consciousness or awareness (Type 2 focal); focal seizures evolving to bilateral generalized convulsive seizures (Type 3 focal); and tonic-clonic, tonic, clonic, or atonic seizures that were countable. Participants who withdrew from the trial during the treatment period were considered non-responders.
Outcome measures
| Measure |
GWP42003-P (Double-blind Phase)
n=124 Participants
Participants who had received GWP42003-P during the double-blind phase and then GWP42003-P in the OLE phase.
|
Placebo (Double-blind Phase)
n=75 Participants
Participants who had received placebo during double-blind phase and then GWP42003-P in the OLE phase.
|
|---|---|---|
|
Number of Participants Considered Treatment Responders During the OLE Treatment Period
≥ 50% reduction: Yes
|
70 Participants
|
36 Participants
|
|
Number of Participants Considered Treatment Responders During the OLE Treatment Period
≥ 50% reduction: No
|
54 Participants
|
39 Participants
|
SECONDARY outcome
Timeframe: OLE Day 1 and up to 4 yearsPopulation: Caregiver Global Impression of Change and Subject Global Impression of Change were assessed in the OLE Safety Analysis Set in participants with available data.
The CGIC comprised the following question to be rated on a 7-point scale (1, Very Much Improved; 2, Much Improved; 3, Slightly Improved; 4, No Change; 5, Slightly Worse; 6, Much Worse; 7, Very Much Worse): "Since your child started treatment, please assess the status of your child's overall condition (comparing their condition now to their condition before treatment)." The SGIC comprised the following question to be rated on a 7-point scale (1, Very Much Improved; 2, Much Improved; 3, Slightly Improved; 4, No Change; 5, Slightly Worse; 6, Much Worse; 7, Very Much Worse): "Since you started treatment, please assess the status of your overall condition (comparing your condition now to your condition before treatment)." The average CGIC and SGIC scores are being reported, with higher values indicating worse condition.
Outcome measures
| Measure |
GWP42003-P (Double-blind Phase)
n=40 Participants
Participants who had received GWP42003-P during the double-blind phase and then GWP42003-P in the OLE phase.
|
Placebo (Double-blind Phase)
n=28 Participants
Participants who had received placebo during double-blind phase and then GWP42003-P in the OLE phase.
|
|---|---|---|
|
Caregiver Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC) Score During the OLE Treatment Period
Caregiver
|
3.2 score on a scale
Standard Deviation 1.58
|
3.4 score on a scale
Standard Deviation 1.12
|
|
Caregiver Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC) Score During the OLE Treatment Period
Subjects
|
4.0 score on a scale
Standard Deviation 0.0
|
2.7 score on a scale
Standard Deviation 1.53
|
|
Caregiver Global Impression of Change (CGIC) and Subject Global Impression of Change (SGIC) Score During the OLE Treatment Period
Combined Caregiver and Subjects
|
3.2 score on a scale
Standard Deviation 1.56
|
3.3 score on a scale
Standard Deviation 1.16
|
SECONDARY outcome
Timeframe: OLE Day 1 up to 4 yearsPopulation: Total seizure frequency was assessed in the OLE Safety Analysis Set.
Total seizures included all seizure types, eg. combination of TSC-associated and other seizures. TSC-associated seizures included: focal motor seizures without impairment of consciousness or awareness (Type 1 focal motor); focal seizures with impairment of consciousness or awareness (Type 2 focal); focal seizures evolving to bilateral generalized convulsive seizures (Type 3 focal); and tonic-clonic, tonic, clonic, or atonic seizures that were countable. A negative percent change from baseline indicates improvement in total seizure frequency.
Outcome measures
| Measure |
GWP42003-P (Double-blind Phase)
n=124 Participants
Participants who had received GWP42003-P during the double-blind phase and then GWP42003-P in the OLE phase.
|
Placebo (Double-blind Phase)
n=75 Participants
Participants who had received placebo during double-blind phase and then GWP42003-P in the OLE phase.
|
|---|---|---|
|
Percent Change From Baseline in Total Seizure Frequency During the OLE Treatment Period
|
-55.18 percent change
Interval -84.21 to -11.95
|
-46.76 percent change
Interval -76.22 to -19.77
|
Adverse Events
Placebo (Double-blind Phase)
Serious events: 38 serious events
Other events: 117 other events
Deaths: 1 deaths
GWP42003-P (Double-blind Phase)
Serious events: 18 serious events
Other events: 75 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo (Double-blind Phase)
n=124 participants at risk
Participants who had received placebo during double-blind phase and then GWP42003-P in the OLE phase.
|
GWP42003-P (Double-blind Phase)
n=75 participants at risk
Participants who had received GWP42003-P during the double-blind phase and then GWP42003-P in the OLE phase.
|
|---|---|---|
|
Investigations
Investigation
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Blood and lymphatic system disorders
Leukocytosis
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Gastrointestinal disorders
Vomiting
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
General disorders
Pyrexia
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
General disorders
Soft tissue inflammation
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Adenoiditis
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Adenovirus infection
|
1.6%
2/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Enterovirus infection
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Gastroenteritis
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Gastroenteritis astroviral
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Gastroenteritis viral
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Implant site infection
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Infective myositis
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Influenza
|
4.0%
5/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Laryngitis
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Parainfluenzae virus infection
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Pharyngitis
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Pneumonia
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Pneumonia bacterial
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Pneumonia viral
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Respiratory tract infection
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Rhinovirus infection
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Septic shock
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Injury, poisoning and procedural complications
Fall
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Injury, poisoning and procedural complications
Head injury
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Alanine aminotransferase increased
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Anticonvulsant drug level increased
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Aspartate aminotransferase increased
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Astrovirus test positive
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Blood bilirubin increased
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Eosinophil count increased
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Influenza A virus test positive
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Liver function test abnormal
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Liver function test increased
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Platelet count decreased
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Respiratory syncytial virus test positive
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Sapovirus test positive
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Transaminases increased
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
2.7%
2/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Weight decreased
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Metabolism and nutrition disorders
Acidosis
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Metabolism and nutrition disorders
Dehydration
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
2.7%
2/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Metabolism and nutrition disorders
Fluid intake reduced
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kidney angiomyolipoma
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Ataxia
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Change in seizure presentation
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Dizziness
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Encephalopathy
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Epileptic encephalopathy
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Lethargy
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Memory impairment
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Postictal state
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Sedation
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Seizure
|
9.7%
12/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
5.3%
4/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Seizure cluster
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Status epilepticus
|
7.3%
9/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Syncope
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Psychiatric disorders
Mental status changes
|
1.6%
2/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Respiratory, thoracic and mediastinal disorders
Lung infiltration
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
0.00%
0/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Social circumstances
Alcohol use
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
Other adverse events
| Measure |
Placebo (Double-blind Phase)
n=124 participants at risk
Participants who had received placebo during double-blind phase and then GWP42003-P in the OLE phase.
|
GWP42003-P (Double-blind Phase)
n=75 participants at risk
Participants who had received GWP42003-P during the double-blind phase and then GWP42003-P in the OLE phase.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
2.7%
2/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
4.0%
3/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Gastrointestinal disorders
Constipation
|
9.7%
12/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
12.0%
9/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Gastrointestinal disorders
Diarrhoea
|
40.3%
50/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
57.3%
43/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Gastrointestinal disorders
Nausea
|
2.4%
3/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
5.3%
4/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Gastrointestinal disorders
Retching
|
2.4%
3/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
4.0%
3/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Gastrointestinal disorders
Vomiting
|
21.8%
27/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
17.3%
13/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
General disorders
Fatigue
|
5.6%
7/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
13.3%
10/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
General disorders
Pyrexia
|
26.6%
33/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
20.0%
15/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Bronchitis
|
1.6%
2/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
6.7%
5/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Conjunctivitis
|
6.5%
8/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
4.0%
3/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Ear infection
|
4.8%
6/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
4.0%
3/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Gastroenteritis
|
4.0%
5/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
2.7%
2/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Gastroenteritis viral
|
5.6%
7/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
4.0%
3/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Influenza
|
12.9%
16/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
5.3%
4/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Nasopharyngitis
|
15.3%
19/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
21.3%
16/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Otitis media
|
6.5%
8/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
5.3%
4/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Pharyngitis
|
6.5%
8/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
2.7%
2/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Pharyngitis streptococcal
|
10.5%
13/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
5.3%
4/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Pneumonia
|
4.0%
5/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
4.0%
3/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Rhinitis
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Sinusitis
|
5.6%
7/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
2.7%
2/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Upper respiratory tract infection
|
17.7%
22/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
13.3%
10/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Urinary tract infection
|
5.6%
7/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
4.0%
3/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Viral infection
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
6.7%
5/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
4.0%
3/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Injury, poisoning and procedural complications
Accident
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Injury, poisoning and procedural complications
Contusion
|
4.8%
6/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
5.3%
4/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Injury, poisoning and procedural complications
Fall
|
10.5%
13/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
10.7%
8/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Injury, poisoning and procedural complications
Head injury
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Injury, poisoning and procedural complications
Laceration
|
7.3%
9/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
5.3%
4/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.81%
1/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
4.0%
3/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
1.6%
2/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
4.0%
3/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
4.0%
5/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Alanine aminotransferase increased
|
6.5%
8/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
8.0%
6/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Aspartate aminotransferase increased
|
4.8%
6/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
5.3%
4/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Blood prolactin increased
|
1.6%
2/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
4.0%
3/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Gamma-glutamyltransferase increased
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
12.0%
9/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Liver function test increased
|
1.6%
2/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
8.0%
6/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Weight decreased
|
5.6%
7/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
12.0%
9/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Investigations
Weight increased
|
2.4%
3/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
4.0%
3/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.5%
23/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
32.0%
24/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Ataxia
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
6.7%
5/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Dizziness
|
4.0%
5/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
5.3%
4/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Generalised tonic-clonic seizure
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
2.7%
2/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Headache
|
7.3%
9/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
6.7%
5/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Lethargy
|
2.4%
3/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
6.7%
5/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Sedation
|
1.6%
2/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
5.3%
4/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Seizure
|
32.3%
40/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
25.3%
19/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Somnolence
|
12.1%
15/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
32.0%
24/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Psychiatric disorders
Abnormal behaviour
|
4.8%
6/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
6.7%
5/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Psychiatric disorders
Aggression
|
4.0%
5/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
12.0%
9/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Psychiatric disorders
Agitation
|
5.6%
7/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
2.7%
2/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Psychiatric disorders
Anxiety
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
4.0%
3/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Psychiatric disorders
Insomnia
|
4.0%
5/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
8.0%
6/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Psychiatric disorders
Intentional self-injury
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Psychiatric disorders
Irritability
|
7.3%
9/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
6.7%
5/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Psychiatric disorders
Sleep disorder
|
4.8%
6/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
5.3%
4/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Renal and urinary disorders
Urinary retention
|
1.6%
2/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
4.0%
3/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
10.5%
13/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
17.3%
13/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.6%
7/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
6.7%
5/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
4.8%
6/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
6.7%
5/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
4.8%
6/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
5.3%
4/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.5%
8/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
5.3%
4/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Gastrointestinal disorders
Toothache
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
General disorders
Gait disturbance
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.8%
6/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
5.3%
4/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Nervous system disorders
Status epilepticus
|
7.3%
9/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
1.3%
1/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
|
Psychiatric disorders
Mental status changes
|
3.2%
4/124 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
0.00%
0/75 • Treatment-emergent adverse events (TEAEs) were collected from OLE Day 1 up to 4 years.
An adverse event (AE) was defined as any new unfavorable/unintended signs/symptoms (including abnormal laboratory findings), or diagnosis or worsening of a pre-existing condition, which occurred following screening and at any point up to the post-treatment safety follow-up visit, which may or may not be related to the IMP. TEAEs were defined as AEs with a start date on or after the first dose of IMP in the OLE Day 1.
|
Additional Information
Clinical Trial Disclosure & Transparency
Jazz Pharmaceuticals
Phone: 215-832-3750
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER