Trial Outcomes & Findings for Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis (NCT NCT04123405)
NCT ID: NCT04123405
Last Updated: 2021-11-19
Results Overview
The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15. Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
944 participants
Primary outcome timeframe
Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15
Results posted on
2021-11-19
Participant Flow
Participants were enrolled from 42 clinical centers located in Bulgaria, Germany, Moldova and Russia.
Participants were randomized in 1:1:1:1 ratio
Participant milestones
| Measure |
Group A: 600 mg Acetylcysteine
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily).
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
235
|
238
|
238
|
233
|
|
Overall Study
Full Analysis Set
|
235
|
236
|
238
|
230
|
|
Overall Study
Per-protocol Set
|
213
|
215
|
212
|
207
|
|
Overall Study
Safety Set
|
235
|
238
|
238
|
233
|
|
Overall Study
COMPLETED
|
231
|
231
|
235
|
225
|
|
Overall Study
NOT COMPLETED
|
4
|
7
|
3
|
8
|
Reasons for withdrawal
| Measure |
Group A: 600 mg Acetylcysteine
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily).
|
|---|---|---|---|---|
|
Overall Study
Adverse Event
|
1
|
2
|
3
|
3
|
|
Overall Study
Exclusion criteria met
|
1
|
2
|
0
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
3
|
0
|
2
|
|
Overall Study
Contact to subject lost
|
0
|
0
|
0
|
1
|
|
Overall Study
screening failure
|
1
|
0
|
0
|
0
|
Baseline Characteristics
Efficacy and Safety of Acetylcysteine for the Treatment of Acute Uncomplicated Rhinosinusitis
Baseline characteristics by cohort
| Measure |
Group A: 600 mg Acetylcysteine
n=235 Participants
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
n=238 Participants
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
n=238 Participants
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
n=233 Participants
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily).
|
Total
n=944 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
41.0 Years
STANDARD_DEVIATION 13.8 • n=5 Participants
|
40.7 Years
STANDARD_DEVIATION 13.6 • n=7 Participants
|
41.3 Years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
41.1 Years
STANDARD_DEVIATION 14.0 • n=4 Participants
|
41.0 Years
STANDARD_DEVIATION 13.6 • n=21 Participants
|
|
Sex: Female, Male
Female
|
128 Participants
n=5 Participants
|
142 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
141 Participants
n=4 Participants
|
556 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
107 Participants
n=5 Participants
|
96 Participants
n=7 Participants
|
93 Participants
n=5 Participants
|
92 Participants
n=4 Participants
|
388 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
230 Participants
n=5 Participants
|
235 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
231 Participants
n=4 Participants
|
928 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Asian
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period.
The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15. Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.
Outcome measures
| Measure |
Group A: 600 mg Acetylcysteine
n=235 Participants
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
n=236 Participants
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
n=238 Participants
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
n=230 Participants
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
|---|---|---|---|---|
|
Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Full Analysis Set
|
-4.8213 Score on a scale
Standard Deviation 1.98247
|
-4.7394 Score on a scale
Standard Deviation 1.99090
|
-4.7758 Score on a scale
Standard Deviation 1.96938
|
-5.0180 Score on a scale
Standard Deviation 1.98262
|
PRIMARY outcome
Timeframe: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation.
The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15. Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.
Outcome measures
| Measure |
Group A: 600 mg Acetylcysteine
n=213 Participants
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
n=215 Participants
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
n=212 Participants
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
n=207 Participants
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
|---|---|---|---|---|
|
Mean Change From Baseline in the Daily Major Symptom Score (MSS) Over the Entire Treatment Period, Per-Protocol Set
|
-4.9085 Score on a scale
Standard Deviation 1.92431
|
-4.8688 Score on a scale
Standard Deviation 1.84448
|
-4.8002 Score on a scale
Standard Deviation 1.90569
|
-5.1256 Score on a scale
Standard Deviation 1.95072
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period.
Time to onset of action was defined as first day of active treatment on which MSS showed statistically significant (p value\<0.05) improvement from placebo.
Outcome measures
| Measure |
Group A: 600 mg Acetylcysteine
n=235 Participants
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
n=236 Participants
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
n=238 Participants
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
|---|---|---|---|---|
|
Time to Onset of Action, Full Analysis Set
|
NA Days
There was no statistically significant improvement of the drug from placebo on any day
|
NA Days
There was no statistically significant improvement of the drug from placebo on any day
|
NA Days
There was no statistically significant improvement of the drug from placebo on any day
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation.
Time to onset of action was defined as first day of active treatment on which MSS showed statistically significant (p value\<0.05) improvement from placebo.
Outcome measures
| Measure |
Group A: 600 mg Acetylcysteine
n=213 Participants
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
n=215 Participants
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
n=212 Participants
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
|---|---|---|---|---|
|
Time to Onset of Action, Per-Protocol Set
|
NA Days
There was no statistically significant improvement of the drug from placebo on any day
|
NA Days
There was no statistically significant improvement of the drug from placebo on any day
|
NA Days
There was no statistically significant improvement of the drug from placebo on any day
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period.
The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15. Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.
Outcome measures
| Measure |
Group A: 600 mg Acetylcysteine
n=235 Participants
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
n=236 Participants
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
n=238 Participants
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
n=230 Participants
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
|---|---|---|---|---|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
Day 1 (Baseline)
|
9.634 Score on a scale
Standard Deviation 1.1181
|
9.640 Score on a scale
Standard Deviation 1.0647
|
9.702 Score on a scale
Standard Deviation 1.0101
|
9.683 Score on a scale
Standard Deviation 1.0652
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
Day 2
|
9.021 Score on a scale
Standard Deviation 2.0348
|
9.004 Score on a scale
Standard Deviation 1.9883
|
9.038 Score on a scale
Standard Deviation 2.1235
|
9.074 Score on a scale
Standard Deviation 1.9866
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
Day 3
|
8.485 Score on a scale
Standard Deviation 2.3376
|
8.513 Score on a scale
Standard Deviation 2.2303
|
8.416 Score on a scale
Standard Deviation 2.4390
|
8.609 Score on a scale
Standard Deviation 2.1298
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
Day 4
|
7.821 Score on a scale
Standard Deviation 2.4482
|
7.695 Score on a scale
Standard Deviation 2.5130
|
7.723 Score on a scale
Standard Deviation 2.7156
|
7.761 Score on a scale
Standard Deviation 2.5058
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
Day 5
|
6.983 Score on a scale
Standard Deviation 2.7284
|
6.979 Score on a scale
Standard Deviation 2.5706
|
7.013 Score on a scale
Standard Deviation 2.7490
|
6.917 Score on a scale
Standard Deviation 2.6312
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
Day 6
|
6.323 Score on a scale
Standard Deviation 2.7807
|
6.203 Score on a scale
Standard Deviation 2.8719
|
6.315 Score on a scale
Standard Deviation 2.7980
|
6.039 Score on a scale
Standard Deviation 2.7838
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
Day 7
|
5.528 Score on a scale
Standard Deviation 2.9747
|
5.538 Score on a scale
Standard Deviation 2.7449
|
5.576 Score on a scale
Standard Deviation 2.8508
|
5.126 Score on a scale
Standard Deviation 2.7096
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
Day 8
|
4.766 Score on a scale
Standard Deviation 2.8631
|
4.750 Score on a scale
Standard Deviation 2.6755
|
4.891 Score on a scale
Standard Deviation 2.7598
|
4.387 Score on a scale
Standard Deviation 2.6004
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
Day 9
|
4.204 Score on a scale
Standard Deviation 2.8149
|
4.322 Score on a scale
Standard Deviation 2.7254
|
4.445 Score on a scale
Standard Deviation 2.7381
|
3.839 Score on a scale
Standard Deviation 2.5924
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
Day 10
|
3.634 Score on a scale
Standard Deviation 2.6815
|
3.763 Score on a scale
Standard Deviation 2.6391
|
3.845 Score on a scale
Standard Deviation 2.6634
|
3.404 Score on a scale
Standard Deviation 2.6805
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
Day 11
|
3.051 Score on a scale
Standard Deviation 2.5229
|
3.284 Score on a scale
Standard Deviation 2.6658
|
3.256 Score on a scale
Standard Deviation 2.5716
|
2.843 Score on a scale
Standard Deviation 2.6469
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
Day 12
|
2.609 Score on a scale
Standard Deviation 2.5200
|
2.754 Score on a scale
Standard Deviation 2.5680
|
2.756 Score on a scale
Standard Deviation 2.3795
|
2.413 Score on a scale
Standard Deviation 2.5608
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
Day 13
|
2.038 Score on a scale
Standard Deviation 2.4202
|
2.246 Score on a scale
Standard Deviation 2.5296
|
2.218 Score on a scale
Standard Deviation 2.4293
|
1.943 Score on a scale
Standard Deviation 2.4174
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
Day 14
|
1.583 Score on a scale
Standard Deviation 2.3289
|
1.941 Score on a scale
Standard Deviation 2.5375
|
1.836 Score on a scale
Standard Deviation 2.3300
|
1.596 Score on a scale
Standard Deviation 2.3637
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Full Analysis Set
Day 15
|
1.332 Score on a scale
Standard Deviation 2.1485
|
1.614 Score on a scale
Standard Deviation 2.4459
|
1.634 Score on a scale
Standard Deviation 2.3178
|
1.352 Score on a scale
Standard Deviation 2.1882
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14 and 15Population: Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation.
The MSS combines the 5 most relevant symptoms of rhinosinusitis based on expert clinician recommendations (rhinorrhea/ anterior discharge, postnasal drip, nasal congestion, headache, and facial pain/pressure). The patient rated the severity of each of the five symptoms of the MSS using a four-point rating scale of increasing severity (0 = none/not present, 1 = mild, 2 = moderate, 3 = severe). The MSS is then the sum of single ratings with a possible range from 0 to 15. Mean change from baseline in the daily Major Symptom Score (MSS) over the entire treatment period was calculated as the average total score from Day 2 to 15 compared to Baseline (Day 1). Negative change from baseline means improvement.
Outcome measures
| Measure |
Group A: 600 mg Acetylcysteine
n=213 Participants
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
n=215 Participants
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
n=212 Participants
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
n=207 Participants
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
|---|---|---|---|---|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
Day 1 (Baseline)
|
9.657 Score on a scale
Standard Deviation 1.1201
|
9.628 Score on a scale
Standard Deviation 1.0595
|
9.698 Score on a scale
Standard Deviation 1.0319
|
9.676 Score on a scale
Standard Deviation 1.0823
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
Day 2
|
9.080 Score on a scale
Standard Deviation 2.0160
|
8.935 Score on a scale
Standard Deviation 2.0268
|
9.127 Score on a scale
Standard Deviation 2.0089
|
9.068 Score on a scale
Standard Deviation 2.0278
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
Day 3
|
8.545 Score on a scale
Standard Deviation 2.2890
|
8.395 Score on a scale
Standard Deviation 2.2583
|
8.528 Score on a scale
Standard Deviation 2.2591
|
8.594 Score on a scale
Standard Deviation 2.1921
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
Day 4
|
7.803 Score on a scale
Standard Deviation 2.4779
|
7.577 Score on a scale
Standard Deviation 2.5472
|
7.816 Score on a scale
Standard Deviation 2.5849
|
7.739 Score on a scale
Standard Deviation 2.5750
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
Day 5
|
6.962 Score on a scale
Standard Deviation 2.7401
|
6.874 Score on a scale
Standard Deviation 2.5865
|
7.061 Score on a scale
Standard Deviation 2.6522
|
6.821 Score on a scale
Standard Deviation 2.6717
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
Day 6
|
6.315 Score on a scale
Standard Deviation 2.7914
|
6.093 Score on a scale
Standard Deviation 2.8809
|
6.349 Score on a scale
Standard Deviation 2.7000
|
5.937 Score on a scale
Standard Deviation 2.8354
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
Day 7
|
5.479 Score on a scale
Standard Deviation 2.9550
|
5.400 Score on a scale
Standard Deviation 2.7151
|
5.604 Score on a scale
Standard Deviation 2.7800
|
4.981 Score on a scale
Standard Deviation 2.7163
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
Day 8
|
4.685 Score on a scale
Standard Deviation 2.8250
|
4.605 Score on a scale
Standard Deviation 2.6399
|
4.892 Score on a scale
Standard Deviation 2.7421
|
4.237 Score on a scale
Standard Deviation 2.5914
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
Day 9
|
4.117 Score on a scale
Standard Deviation 2.7558
|
4.181 Score on a scale
Standard Deviation 2.6773
|
4.382 Score on a scale
Standard Deviation 2.6734
|
3.652 Score on a scale
Standard Deviation 2.5495
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
Day 10
|
3.521 Score on a scale
Standard Deviation 2.6127
|
3.628 Score on a scale
Standard Deviation 2.5174
|
3.741 Score on a scale
Standard Deviation 2.5507
|
3.222 Score on a scale
Standard Deviation 2.6197
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
Day 11
|
2.934 Score on a scale
Standard Deviation 2.4039
|
3.144 Score on a scale
Standard Deviation 2.5214
|
3.146 Score on a scale
Standard Deviation 2.4538
|
2.705 Score on a scale
Standard Deviation 2.6042
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
Day 12
|
2.493 Score on a scale
Standard Deviation 2.3485
|
2.572 Score on a scale
Standard Deviation 2.3785
|
2.608 Score on a scale
Standard Deviation 2.2228
|
2.300 Score on a scale
Standard Deviation 2.4902
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
Day 13
|
1.897 Score on a scale
Standard Deviation 2.2146
|
2.065 Score on a scale
Standard Deviation 2.2949
|
2.085 Score on a scale
Standard Deviation 2.2013
|
1.816 Score on a scale
Standard Deviation 2.3077
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
Day 14
|
1.432 Score on a scale
Standard Deviation 2.0812
|
1.749 Score on a scale
Standard Deviation 2.2779
|
1.708 Score on a scale
Standard Deviation 2.1128
|
1.444 Score on a scale
Standard Deviation 2.2198
|
|
Major Symptom Score (MSS) Development Over the Course of the Study, Per-protocol Set
Day 15
|
1.221 Score on a scale
Standard Deviation 1.9530
|
1.409 Score on a scale
Standard Deviation 2.1312
|
1.524 Score on a scale
Standard Deviation 2.0846
|
1.193 Score on a scale
Standard Deviation 1.9636
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 7 and Day 14Population: Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period.
SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL.
Outcome measures
| Measure |
Group A: 600 mg Acetylcysteine
n=235 Participants
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
n=236 Participants
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
n=238 Participants
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
n=230 Participants
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
|---|---|---|---|---|
|
Sino-Nasal Outcome Test (SNOT-22) by Visit, Full Analysis Set
Day 1 (Baseline)
|
37.8 Score on a scale
Standard Deviation 16.89
|
36.3 Score on a scale
Standard Deviation 15.82
|
36.7 Score on a scale
Standard Deviation 16.21
|
36.3 Score on a scale
Standard Deviation 17.00
|
|
Sino-Nasal Outcome Test (SNOT-22) by Visit, Full Analysis Set
Day 7
|
23.6 Score on a scale
Standard Deviation 15.01
|
21.2 Score on a scale
Standard Deviation 13.14
|
22.3 Score on a scale
Standard Deviation 13.95
|
21.1 Score on a scale
Standard Deviation 13.56
|
|
Sino-Nasal Outcome Test (SNOT-22) by Visit, Full Analysis Set
Day 14
|
7.2 Score on a scale
Standard Deviation 10.80
|
6.9 Score on a scale
Standard Deviation 11.15
|
7.0 Score on a scale
Standard Deviation 10.07
|
6.5 Score on a scale
Standard Deviation 10.28
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 7 and Day 14Population: Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation.
SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL.
Outcome measures
| Measure |
Group A: 600 mg Acetylcysteine
n=213 Participants
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
n=215 Participants
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
n=212 Participants
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
n=207 Participants
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
|---|---|---|---|---|
|
Sino-Nasal Outcome Test (SNOT-22) by Visit, Per Protocol Set
Day 1 (Baseline)
|
37.7 Score on a scale
Standard Deviation 16.64
|
36.7 Score on a scale
Standard Deviation 15.89
|
36.4 Score on a scale
Standard Deviation 15.86
|
36.2 Score on a scale
Standard Deviation 16.88
|
|
Sino-Nasal Outcome Test (SNOT-22) by Visit, Per Protocol Set
Day 7
|
23.3 Score on a scale
Standard Deviation 14.92
|
21.2 Score on a scale
Standard Deviation 13.32
|
22.2 Score on a scale
Standard Deviation 14.27
|
21.0 Score on a scale
Standard Deviation 13.78
|
|
Sino-Nasal Outcome Test (SNOT-22) by Visit, Per Protocol Set
Day 14
|
6.9 Score on a scale
Standard Deviation 10.49
|
7.1 Score on a scale
Standard Deviation 11.43
|
6.8 Score on a scale
Standard Deviation 9.67
|
6.6 Score on a scale
Standard Deviation 10.50
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 7 and Day 14Population: Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period.
SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. A negative change from baseline in SNOT-22 is considered a favorable outcome.
Outcome measures
| Measure |
Group A: 600 mg Acetylcysteine
n=235 Participants
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
n=236 Participants
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
n=238 Participants
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
n=230 Participants
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
|---|---|---|---|---|
|
Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Full Analysis Set
Day 7
|
-35.8 Score on a scale
Standard Deviation 33.25
|
-38.2 Score on a scale
Standard Deviation 37.48
|
-36.7 Score on a scale
Standard Deviation 34.61
|
-39.6 Score on a scale
Standard Deviation 30.42
|
|
Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Full Analysis Set
Day 14
|
-79.3 Score on a scale
Standard Deviation 31.27
|
-78.9 Score on a scale
Standard Deviation 31.11
|
-78.6 Score on a scale
Standard Deviation 30.53
|
-81.5 Score on a scale
Standard Deviation 26.54
|
SECONDARY outcome
Timeframe: Baseline (Day 1), Day 7 and Day 14Population: Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation.
SNOT-22 Questionnaire is a disease specific Health-Related Quality of Life (HRQoL) measure that comprises a list of 22 symptoms and social or emotional consequences of the nasal disorder. Every participant is asked to rate how severe each problem had been on a scale from 0 (no problem) to 5 (problem as bad as it can be). The total score is the sum of the scores for all 22 items, ranging from 0 to 110, with a lower score indicating better HRQoL. A negative change from baseline in SNOT-22 is considered a favorable outcome.
Outcome measures
| Measure |
Group A: 600 mg Acetylcysteine
n=213 Participants
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
n=215 Participants
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
n=212 Participants
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
n=207 Participants
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
|---|---|---|---|---|
|
Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Per Protocol Set
Day 7
|
-36.4 Score on a scale
Standard Deviation 32.64
|
-39.5 Score on a scale
Standard Deviation 36.68
|
-36.7 Score on a scale
Standard Deviation 33.44
|
-39.6 Score on a scale
Standard Deviation 30.60
|
|
Sino-Nasal Outcome Test (SNOT-22) by Change to Baseline, Per Protocol Set
Day 14
|
-79.8 Score on a scale
Standard Deviation 30.90
|
-78.6 Score on a scale
Standard Deviation 31.77
|
-79.1 Score on a scale
Standard Deviation 30.16
|
-81.0 Score on a scale
Standard Deviation 27.10
|
SECONDARY outcome
Timeframe: Day 4, 7, 10 and 15Population: Full-Analysis Set (FAS) included all randomized patients who received at least one dose of the trial medication and who had at least one post-baseline assessment of MSS during the double-blind treatment period.
Number of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator were reported.
Outcome measures
| Measure |
Group A: 600 mg Acetylcysteine
n=235 Participants
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
n=236 Participants
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
n=238 Participants
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
n=230 Participants
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
|---|---|---|---|---|
|
Number of Responders and Non-responders to Treatment, Full Analysis Set
Day 4 · Responders
|
148 Participants
|
152 Participants
|
151 Participants
|
150 Participants
|
|
Number of Responders and Non-responders to Treatment, Full Analysis Set
Day 4 · Non-responders
|
85 Participants
|
83 Participants
|
86 Participants
|
79 Participants
|
|
Number of Responders and Non-responders to Treatment, Full Analysis Set
Day 7 · Responders
|
209 Participants
|
206 Participants
|
212 Participants
|
209 Participants
|
|
Number of Responders and Non-responders to Treatment, Full Analysis Set
Day 7 · Non-responders
|
23 Participants
|
29 Participants
|
15 Participants
|
18 Participants
|
|
Number of Responders and Non-responders to Treatment, Full Analysis Set
Day 10 · Responders
|
225 Participants
|
225 Participants
|
230 Participants
|
219 Participants
|
|
Number of Responders and Non-responders to Treatment, Full Analysis Set
Day 10 · Non-responders
|
6 Participants
|
7 Participants
|
5 Participants
|
6 Participants
|
|
Number of Responders and Non-responders to Treatment, Full Analysis Set
Day 15 · Responders
|
230 Participants
|
226 Participants
|
230 Participants
|
224 Participants
|
|
Number of Responders and Non-responders to Treatment, Full Analysis Set
Day 15 · Non-responders
|
4 Participants
|
6 Participants
|
8 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Day 4, 7, 10 and 15Population: Per-Protocol Set (PPS) included all FAS-evaluable patients who completed the double-blind treatment period without major protocol violations that could affect the efficacy evaluation.
Number of responders and non-responders to treatment based on the assessment of overall response to treatment by the investigator were reported.
Outcome measures
| Measure |
Group A: 600 mg Acetylcysteine
n=213 Participants
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
n=215 Participants
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
n=212 Participants
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
n=207 Participants
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
|---|---|---|---|---|
|
Number of Responders and Non-responders to Treatment, Per-Protocol Set
Day 4 · Responders
|
138 Participants
|
140 Participants
|
132 Participants
|
134 Participants
|
|
Number of Responders and Non-responders to Treatment, Per-Protocol Set
Day 4 · Non-responders
|
75 Participants
|
75 Participants
|
80 Participants
|
73 Participants
|
|
Number of Responders and Non-responders to Treatment, Per-Protocol Set
Day 7 · Responders
|
192 Participants
|
190 Participants
|
191 Participants
|
192 Participants
|
|
Number of Responders and Non-responders to Treatment, Per-Protocol Set
Day 7 · Non-responders
|
21 Participants
|
25 Participants
|
21 Participants
|
15 Participants
|
|
Number of Responders and Non-responders to Treatment, Per-Protocol Set
Day 10 · Responders
|
207 Participants
|
210 Participants
|
209 Participants
|
202 Participants
|
|
Number of Responders and Non-responders to Treatment, Per-Protocol Set
Day 10 · Non-responders
|
6 Participants
|
5 Participants
|
3 Participants
|
5 Participants
|
|
Number of Responders and Non-responders to Treatment, Per-Protocol Set
Day 15 · Responders
|
211 Participants
|
210 Participants
|
206 Participants
|
205 Participants
|
|
Number of Responders and Non-responders to Treatment, Per-Protocol Set
Day 15 · Non-responders
|
2 Participants
|
5 Participants
|
6 Participants
|
2 Participants
|
Adverse Events
Group A: 600 mg Acetylcysteine
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Group B: 1200 mg Acetylcysteine
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group C: 2400 mg Acetylcysteine
Serious events: 0 serious events
Other events: 15 other events
Deaths: 0 deaths
Group D: Placebo
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group A: 600 mg Acetylcysteine
n=235 participants at risk
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
n=238 participants at risk
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
n=238 participants at risk
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
n=233 participants at risk
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily).
|
|---|---|---|---|---|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.43%
1/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.43%
1/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.43%
1/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Nervous system disorders
Subarachnoid haemorrhage
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.43%
1/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
Other adverse events
| Measure |
Group A: 600 mg Acetylcysteine
n=235 participants at risk
one tablet test product plus three tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group B: 1200 mg Acetylcysteine
n=238 participants at risk
two tablets test product plus two tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group C: 2400 mg Acetylcysteine
n=238 participants at risk
four tablets test product per day (taken as two tablets dissolved in a glass of water, twice daily)
|
Group D: Placebo
n=233 participants at risk
four tablets placebo per day (taken as two tablets dissolved in a glass of water, twice daily).
|
|---|---|---|---|---|
|
Ear and labyrinth disorders
Ear congestion
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.84%
2/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.43%
1/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.84%
2/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.43%
1/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
1.3%
3/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.84%
2/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Gastrointestinal disorders
Nausea
|
0.43%
1/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.43%
1/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
General disorders
Asthenia
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
General disorders
Pyrexia
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Infections and infestations
Acute sinusitis
|
0.43%
1/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.43%
1/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Infections and infestations
COVID-19
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Infections and infestations
Otitis media bacterial
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.43%
1/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Infections and infestations
Pulpitis dental
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Infections and infestations
Sinusitis bacterial
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.43%
1/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Investigations
Hepatic enzyme increased
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.43%
1/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Investigations
Human chorionic gonadotropin increased
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Nervous system disorders
Headache
|
0.85%
2/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.84%
2/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.43%
1/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal crusting
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.43%
1/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal obstruction
|
0.43%
1/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.43%
1/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.43%
1/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.43%
1/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Vascular disorders
Hypertension
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
|
Vascular disorders
Hypertensive crisis
|
0.00%
0/235 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.42%
1/238 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
0.00%
0/233 • Adverse events were collected from first dose of study treatment up to maximum duration of 22 days.
Any signs or symptoms were collected from first dose of study treatment up to maximum duration of 22 days.
|
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 (ie, data from all sites) in the clinical trial.
- Publication restrictions are in place
Restriction type: OTHER