Trial Outcomes & Findings for Phase IIIb, Open-label, Multi-center Study to Evaluate Safety, Tolerability and Efficacy of OAV101 Administered Intrathecally to Participants With SMA Who Discontinued Treatment With Nusinersen or Risdiplam (NCT NCT05386680)
NCT ID: NCT05386680
Last Updated: 2026-01-13
Results Overview
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. The occurrence of AEs must be sought by non-directive questioning of the participant at each visit during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination findings, laboratory test findings, or other assessments.
COMPLETED
PHASE3
27 participants
Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
2026-01-13
Participant Flow
Participant milestones
| Measure |
OAV101 1.2x1014 vg - All Participants
Intrathecal administration of OAV101 at a dose of 1.2 x 10\^14 vector genomes, one time dose
|
|---|---|
|
Overall Study
STARTED
|
27
|
|
Overall Study
COMPLETED
|
25
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
| Measure |
OAV101 1.2x1014 vg - All Participants
Intrathecal administration of OAV101 at a dose of 1.2 x 10\^14 vector genomes, one time dose
|
|---|---|
|
Overall Study
Guardian decision
|
2
|
Baseline Characteristics
Phase IIIb, Open-label, Multi-center Study to Evaluate Safety, Tolerability and Efficacy of OAV101 Administered Intrathecally to Participants With SMA Who Discontinued Treatment With Nusinersen or Risdiplam
Baseline characteristics by cohort
| Measure |
OAV101 1.2x1014 vg - All Participants
n=27 Participants
Intrathecal administration of OAV101 at a dose of 1.2 x 10\^14 vector genomes, one time dose
|
|---|---|
|
Age, Continuous
|
7.40 years
STANDARD_DEVIATION 3.348 • n=210 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=210 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=210 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=210 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=210 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=210 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
7 Participants
n=210 Participants
|
PRIMARY outcome
Timeframe: Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.Population: Full analysis set - all treated participants
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. The occurrence of AEs must be sought by non-directive questioning of the participant at each visit during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination findings, laboratory test findings, or other assessments.
Outcome measures
| Measure |
OAV101 1.2x1014 vg - All Participants
n=27 Participants
Intrathecal administration of OAV101 at a dose of 1.2 x 10\^14 vector genomes, one time dose
|
|---|---|
|
Overview of Treatment-emergent Adverse Events by Age Subgroup
Any serious treatment-emergent adverse event
|
4 Participants
|
|
Overview of Treatment-emergent Adverse Events by Age Subgroup
Any serious treatment-emergent adverse event related to study treatment
|
0 Participants
|
|
Overview of Treatment-emergent Adverse Events by Age Subgroup
Any treatment-emergent adverse event
|
27 Participants
|
|
Overview of Treatment-emergent Adverse Events by Age Subgroup
Any treatment-emergent adverse event related to study treatment
|
13 Participants
|
|
Overview of Treatment-emergent Adverse Events by Age Subgroup
Any severe treatment-emergent adverse event
|
1 Participants
|
|
Overview of Treatment-emergent Adverse Events by Age Subgroup
Any treatment-emergent adverse event leading to study discontinuation
|
0 Participants
|
|
Overview of Treatment-emergent Adverse Events by Age Subgroup
Any treatment-emergent adverse event leading to death
|
0 Participants
|
|
Overview of Treatment-emergent Adverse Events by Age Subgroup
Any treatment-emergent adverse event of special interest
|
13 Participants
|
PRIMARY outcome
Timeframe: Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.Population: Full analysis set - all treated participants
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. The occurrence of AEs must be sought by non-directive questioning of the participant at each visit during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination findings, laboratory test findings, or other assessments.
Outcome measures
| Measure |
OAV101 1.2x1014 vg - All Participants
n=27 Participants
Intrathecal administration of OAV101 at a dose of 1.2 x 10\^14 vector genomes, one time dose
|
|---|---|
|
Treatment-emergent Adverse Events Related to Treatment by System Organ Class, Preferred Term, Age Subgroup (>= 10%)
Number of participants with at least one event
|
13 Participants
|
|
Treatment-emergent Adverse Events Related to Treatment by System Organ Class, Preferred Term, Age Subgroup (>= 10%)
Gastrointestinal disorders
|
7 Participants
|
|
Treatment-emergent Adverse Events Related to Treatment by System Organ Class, Preferred Term, Age Subgroup (>= 10%)
-Vomiting
|
6 Participants
|
|
Treatment-emergent Adverse Events Related to Treatment by System Organ Class, Preferred Term, Age Subgroup (>= 10%)
General disorders and administration site conditions
|
5 Participants
|
|
Treatment-emergent Adverse Events Related to Treatment by System Organ Class, Preferred Term, Age Subgroup (>= 10%)
-Pyrexia
|
3 Participants
|
|
Treatment-emergent Adverse Events Related to Treatment by System Organ Class, Preferred Term, Age Subgroup (>= 10%)
Nervous system disorders
|
6 Participants
|
|
Treatment-emergent Adverse Events Related to Treatment by System Organ Class, Preferred Term, Age Subgroup (>= 10%)
-Headache
|
4 Participants
|
PRIMARY outcome
Timeframe: Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.Population: Full analysis set - all treated participants
An adverse event (AE) is any untoward medical occurrence (e.g. any unfavorable and unintended sign \[including abnormal laboratory findings\], symptom or disease) in a clinical investigation participant after providing written informed consent for participation in the study. The occurrence of AEs must be sought by non-directive questioning of the participant at each visit during the study. Adverse events also may be detected when they are volunteered by the participant during or between visits or through physical examination findings, laboratory test findings, or other assessments. An adverse event of special interest (AESI) is primarily defined by using standard Medical Dictionary for Regulatory Activities (MedDRA) queries, and identified as follows: Hepatotoxicity, Transient thrombocytopenia, Thrombotic microangiopathy, Cardiac adverse events, signs and symptoms that may be suggestive dorsal root ganglia toxicity, and new malignancies.
Outcome measures
| Measure |
OAV101 1.2x1014 vg - All Participants
n=27 Participants
Intrathecal administration of OAV101 at a dose of 1.2 x 10\^14 vector genomes, one time dose
|
|---|---|
|
Adverse Events of Special Interest by System Organ Class, Preferred Term, Age Subgroup
-Epistaxis
|
3 Participants
|
|
Adverse Events of Special Interest by System Organ Class, Preferred Term, Age Subgroup
-Contusion
|
2 Participants
|
|
Adverse Events of Special Interest by System Organ Class, Preferred Term, Age Subgroup
-Gastric haemorrhage
|
1 Participants
|
|
Adverse Events of Special Interest by System Organ Class, Preferred Term, Age Subgroup
Hepatotoxicity - Number of participants with at least one event
|
4 Participants
|
|
Adverse Events of Special Interest by System Organ Class, Preferred Term, Age Subgroup
-Hepatic enzyme increased
|
3 Participants
|
|
Adverse Events of Special Interest by System Organ Class, Preferred Term, Age Subgroup
-Hypertransaminasaemia
|
1 Participants
|
|
Adverse Events of Special Interest by System Organ Class, Preferred Term, Age Subgroup
Transient thrombocytopenia - Number of participants with at least one event
|
8 Participants
|
|
Adverse Events of Special Interest by System Organ Class, Preferred Term, Age Subgroup
-Bone contusion
|
1 Participants
|
|
Adverse Events of Special Interest by System Organ Class, Preferred Term, Age Subgroup
-Lower gastrointestinal haemorrhage
|
1 Participants
|
|
Adverse Events of Special Interest by System Organ Class, Preferred Term, Age Subgroup
-Petechiae
|
1 Participants
|
|
Adverse Events of Special Interest by System Organ Class, Preferred Term, Age Subgroup
Signs of dorsal root ganglia toxicity - No. of pts. with at least one event
|
2 Participants
|
|
Adverse Events of Special Interest by System Organ Class, Preferred Term, Age Subgroup
-Paraesthesia
|
1 Participants
|
|
Adverse Events of Special Interest by System Organ Class, Preferred Term, Age Subgroup
-Sensory disturbance
|
1 Participants
|
|
Adverse Events of Special Interest by System Organ Class, Preferred Term, Age Subgroup
Thrombotic microangiopathy - Number of participants with at least one event
|
0 Participants
|
|
Adverse Events of Special Interest by System Organ Class, Preferred Term, Age Subgroup
Cardiac adverse events - Number of participants with at least one event
|
0 Participants
|
|
Adverse Events of Special Interest by System Organ Class, Preferred Term, Age Subgroup
New malignancies - Number of participants with at least one event
|
0 Participants
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Full analysis set - for all treated participants with a valid measurement without a protocol deviation with impact
The Hammersmith Functional Motor Scale Expanded (HFMSE) is a SMA-specific 33-item assessment that is administered by qualified clinical evaluators. Each motor skill item is scored on a 3-point Likert scale from 0 (no response) to 2 (full response), with a total score range of 0 to 66. A higher score indicates a higher ability level.
Outcome measures
| Measure |
OAV101 1.2x1014 vg - All Participants
n=21 Participants
Intrathecal administration of OAV101 at a dose of 1.2 x 10\^14 vector genomes, one time dose
|
|---|---|
|
Change From Baseline at Week 52 Visit in the HFMSE Total Score - Mean (SD)
|
0.17 scores on a scale
Standard Deviation 2.878
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Full analysis set - for all treated participants with a valid measurement without a protocol deviation with impact
The Hammersmith Functional Motor Scale Expanded (HFMSE) is a SMA-specific 33-item assessment that is administered by qualified clinical evaluators. Each motor skill item is scored on a 3-point Likert scale from 0 (no response) to 2 (full response), with a total score range of 0 to 66. A higher score indicates a higher ability level.
Outcome measures
| Measure |
OAV101 1.2x1014 vg - All Participants
n=21 Participants
Intrathecal administration of OAV101 at a dose of 1.2 x 10\^14 vector genomes, one time dose
|
|---|---|
|
Change From Baseline at Week 52 Visit in the HFMSE Total Score - LS Means
|
1.05 scores on a scale
Interval -0.21 to 2.32
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Full analysis set - for all treated participants with a valid measurement without a protocol deviation with impact
The Revised Upper Limb Model (RULM) is a validated, SMA-specific assessment that measures motor performance in the upper limbs from childhood through adulthood in ambulatory and never ambulatory individuals with SMA. The revised version of the test consists of 19 scorable items: 18 items scored on a 0 (unable) to 2 (full achievement) scale, and one item that is scored from 0 (unable) to 1 (able). These item scores are summed to give a total score ranging from 0 to 37 points with lower scores reflecting poorer ability.
Outcome measures
| Measure |
OAV101 1.2x1014 vg - All Participants
n=21 Participants
Intrathecal administration of OAV101 at a dose of 1.2 x 10\^14 vector genomes, one time dose
|
|---|---|
|
Change From Baseline at Week 52 Visit in the RULM Total Score - Mean (SD)
|
0.29 scores on a scale
Standard Deviation 2.849
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Full analysis set - for all treated participants with a valid measurement without a protocol deviation with impact
The Revised Upper Limb Model (RULM) is a validated, SMA-specific assessment that measures motor performance in the upper limbs from childhood through adulthood in ambulatory and never ambulatory individuals with SMA. The revised version of the test consists of 19 scorable items: 18 items scored on a 0 (unable) to 2 (full achievement) scale, and one item that is scored from 0 (unable) to 1 (able). These item scores are summed to give a total score ranging from 0 to 37 points with lower scores reflecting poorer ability.
Outcome measures
| Measure |
OAV101 1.2x1014 vg - All Participants
n=21 Participants
Intrathecal administration of OAV101 at a dose of 1.2 x 10\^14 vector genomes, one time dose
|
|---|---|
|
Change From Baseline at Week 52 Visit in the RULM Total Score - LS Means
|
0.59 scores on a scale
Interval -0.56 to 1.73
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Full analysis set - for all treated participants with a valid measurement without a protocol deviation with impact
The Assessment of Caregiver Experience in Neuromuscular Disease (ACEND) instrument quantifies the caregiver impact experienced by parents/caregivers of children affected with severe neuromuscular diseases, including children with SMA. The total score is on a scale of 0 to 100 with a higher score indicating that caregivers experienced less intense caregiving impact.
Outcome measures
| Measure |
OAV101 1.2x1014 vg - All Participants
n=24 Participants
Intrathecal administration of OAV101 at a dose of 1.2 x 10\^14 vector genomes, one time dose
|
|---|---|
|
Change From Baseline at Week 52 Visit in Assessment of Caregiver Experience in ACEND Instrument Score - Mean (SD)
|
1.43 scores on a scale
Standard Deviation 9.318
|
SECONDARY outcome
Timeframe: Baseline, Week 52Population: Full analysis set - for all treated participants with a valid measurement without a protocol deviation with impact
The Assessment of Caregiver Experience in Neuromuscular Disease (ACEND) instrument quantifies the caregiver impact experienced by parents/caregivers of children affected with severe neuromuscular diseases, including children with SMA. The total score is on a scale of 0 to 100 with a higher score indicating that caregivers experienced less intense caregiving impact.
Outcome measures
| Measure |
OAV101 1.2x1014 vg - All Participants
n=24 Participants
Intrathecal administration of OAV101 at a dose of 1.2 x 10\^14 vector genomes, one time dose
|
|---|---|
|
Change From Baseline at Week 52 Visit in Assessment of Caregiver Experience in ACEND Instrument Score - LS Means
|
1.06 scores on a scale
Interval -2.9 to 5.02
|
Adverse Events
OAV101 1.2x1014 vg - All Participants
Serious adverse events
| Measure |
OAV101 1.2x1014 vg - All Participants
n=27 participants at risk
Intrathecal administration of OAV101 at a dose of 1.2 x 10\^14 vector genomes, one time dose
|
|---|---|
|
Gastrointestinal disorders
Cyclic vomiting syndrome
|
3.7%
1/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
General disorders and administration site conditions
Pyrexia
|
3.7%
1/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Infections and infestations
Bronchitis viral
|
3.7%
1/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Infections and infestations
COVID-19
|
3.7%
1/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Infections and infestations
Gastroenteritis
|
3.7%
1/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Infections and infestations
Pneumonia
|
3.7%
1/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Infections and infestations
Pneumonia aspiration
|
3.7%
1/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Investigations
Influenza virus test positive
|
3.7%
1/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Nervous system disorders
Headache
|
3.7%
1/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
3.7%
1/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
3.7%
1/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory distress
|
3.7%
1/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
Other adverse events
| Measure |
OAV101 1.2x1014 vg - All Participants
n=27 participants at risk
Intrathecal administration of OAV101 at a dose of 1.2 x 10\^14 vector genomes, one time dose
|
|---|---|
|
Metabolism and nutrition disorders
Increased appetite
|
18.5%
5/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
7.4%
2/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Gastrointestinal disorders
Abdominal pain
|
14.8%
4/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
22.2%
6/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Gastrointestinal disorders
Constipation
|
7.4%
2/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
2/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Gastrointestinal disorders
Dysphagia
|
7.4%
2/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Gastrointestinal disorders
Nausea
|
11.1%
3/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Gastrointestinal disorders
Toothache
|
7.4%
2/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Gastrointestinal disorders
Vomiting
|
48.1%
13/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
General disorders and administration site conditions
Fatigue
|
14.8%
4/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
General disorders and administration site conditions
Pyrexia
|
48.1%
13/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
General disorders and administration site conditions
Swelling face
|
7.4%
2/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Infections and infestations
COVID-19
|
14.8%
4/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Infections and infestations
Ear infection
|
14.8%
4/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Infections and infestations
Influenza
|
11.1%
3/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Infections and infestations
Nasopharyngitis
|
55.6%
15/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
3/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Injury, poisoning and procedural complications
Contusion
|
7.4%
2/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Injury, poisoning and procedural complications
Fall
|
11.1%
3/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Investigations
Hepatic enzyme increased
|
11.1%
3/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Investigations
Weight increased
|
18.5%
5/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.4%
2/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
14.8%
4/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
7.4%
2/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.1%
3/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
18.5%
5/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Musculoskeletal and connective tissue disorders
Scoliosis
|
7.4%
2/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Nervous system disorders
Headache
|
29.6%
8/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Nervous system disorders
Tremor
|
14.8%
4/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Psychiatric disorders
Affect lability
|
11.1%
3/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Psychiatric disorders
Initial insomnia
|
7.4%
2/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Psychiatric disorders
Irritability
|
7.4%
2/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.5%
5/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
11.1%
3/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
11.1%
3/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
11.1%
3/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
18.5%
5/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
7.4%
2/27 • Adverse events were reported from single dose of study treatment plus 52 weeks, up to a maximum time period of 52 weeks.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER