Trial Outcomes & Findings for Efficacy and Safety Trial of Pangramin SLIT HDM-mix in Subjects With House Dust Mite Induced Rhinitis (NCT NCT01603056)
NCT ID: NCT01603056
Last Updated: 2016-04-29
Results Overview
Subjects completed symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of six rhinoconjunctivitis symptoms were measured on a scale from 0-3 as follows: 0 = No symptoms. 1. = Mild symptoms. 2. = Moderate symptoms. 3= Severe symptoms. The six symptoms are classified in 2 groups as follows: Nose symptoms: Runny nose, Blocked nose, Sneezing, Itchy nose; Eye symptoms: Gritty feeling/red/itchy eyes, Watery eyes. The six symptom scores were summed to obtain the rhinoconjunctivitis symptoms score with range 0(best) to 18(worst). Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average rhinoconjunctivitis symptoms scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary.
COMPLETED
PHASE3
617 participants
Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).
2016-04-29
Participant Flow
Participant milestones
| Measure |
PANGRAMIN SLIT HDM MIX
Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Placebo
Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
|---|---|---|
|
Overall Study
STARTED
|
413
|
204
|
|
Overall Study
COMPLETED
|
379
|
190
|
|
Overall Study
NOT COMPLETED
|
34
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Efficacy and Safety Trial of Pangramin SLIT HDM-mix in Subjects With House Dust Mite Induced Rhinitis
Baseline characteristics by cohort
| Measure |
PANGRAMIN SLIT HDM MIX
n=400 Participants
Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Placebo
n=200 Participants
Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
20.74 years
STANDARD_DEVIATION 12.98 • n=99 Participants
|
19.47 years
STANDARD_DEVIATION 12.01 • n=107 Participants
|
20.31 years
STANDARD_DEVIATION 12.67 • n=206 Participants
|
|
Sex: Female, Male
Female
|
172 Participants
n=99 Participants
|
87 Participants
n=107 Participants
|
259 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
228 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
341 Participants
n=206 Participants
|
|
Region of Enrollment
China
|
400 participants
n=99 Participants
|
200 participants
n=107 Participants
|
600 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).Population: The analysis was performed in the Full Analysis Set.
Subjects completed symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of six rhinoconjunctivitis symptoms were measured on a scale from 0-3 as follows: 0 = No symptoms. 1. = Mild symptoms. 2. = Moderate symptoms. 3= Severe symptoms. The six symptoms are classified in 2 groups as follows: Nose symptoms: Runny nose, Blocked nose, Sneezing, Itchy nose; Eye symptoms: Gritty feeling/red/itchy eyes, Watery eyes. The six symptom scores were summed to obtain the rhinoconjunctivitis symptoms score with range 0(best) to 18(worst). Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average rhinoconjunctivitis symptoms scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary.
Outcome measures
| Measure |
PANGRAMIN SLIT HDM MIX
n=400 Participants
Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Placebo
n=200 Participants
Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
|---|---|---|
|
The Change From Baseline in Rhinoconjunctivitis Symptoms Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.
|
-1.77 units on a scale (Symptom Score)
Standard Deviation 2.13
|
-1.83 units on a scale (Symptom Score)
Standard Deviation 2.18
|
PRIMARY outcome
Timeframe: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).Population: The analysis was performed in the Full Analysis Set.
Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their rhinoconjunctivitis symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores.The scores of all the medication used were summed to produce the daily rhinoconjunctivitis medication score range from 0 to 32. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome. Baseline was from V1 (Week -8) to V2 (Week 0). The end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and End) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days in diary.
Outcome measures
| Measure |
PANGRAMIN SLIT HDM MIX
n=400 Participants
Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Placebo
n=200 Participants
Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
|---|---|---|
|
The Change From Baseline in Rhinoconjunctivitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.
|
-2.17 units on a scale (Medication Score)
Standard Deviation 2.77
|
-2.16 units on a scale (Medication Score)
Standard Deviation 2.77
|
SECONDARY outcome
Timeframe: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).Population: The analysis was performed in the Full Analysis Set.
Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of 4 rhinitis symptoms were measured on a scale from 0-3 as follows: 0 = No symptoms. 1. = Mild symptoms. 2. = Moderate symptoms. 3= Severe symptoms. The 4 symptoms are as follows: Runny nose, Blocked nose, Sneezing, Itchy nose. The 4 symptom scores were summed to obtain the rhinitis symptoms score with range 0(best) to 12(worst). Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary.
Outcome measures
| Measure |
PANGRAMIN SLIT HDM MIX
n=400 Participants
Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Placebo
n=200 Participants
Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
|---|---|---|
|
The Change From Baseline in Rhinitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.
|
-1.44 units on a scale (Symptom score)
Standard Deviation 1.78
|
-1.48 units on a scale (Symptom score)
Standard Deviation 1.78
|
SECONDARY outcome
Timeframe: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).Population: The analysis was performed in the Full Analysis Set.
Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of 2 conjunctivitis symptoms were measured on a scale from 0-3 as follows: 0 = No symptoms. 1. = Mild symptoms. 2. = Moderate symptoms. 3= Severe symptoms. The 2 symptoms as follows: Gritty feeling/red/itchy eyes, Watery eyes. The 2 symptom scores were summed to obtain the conjunctivitis symptoms score with range 0(best) to 6(worst). Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary.
Outcome measures
| Measure |
PANGRAMIN SLIT HDM MIX
n=400 Participants
Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Placebo
n=200 Participants
Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
|---|---|---|
|
The Change From Baseline in Conjunctivitis Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.
|
-0.36 units on a scale(Symptom score)
Standard Deviation 0.61
|
-0.38 units on a scale(Symptom score)
Standard Deviation 0.71
|
SECONDARY outcome
Timeframe: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).Population: The analysis was performed in the Full Analysis Set.
Subjects were instructed by the investigator on how to complete symptom assessments and recorded the results in the patient diary cards on a daily basis. A total of 4 Asthma symptoms were measured on a scale from 0-3 as follows: 0 = No symptoms. 1. = Mild symptoms. 2. = Moderate symptoms. 3= Severe symptoms. The 4 symptoms as follows: Cough, Wheeze, Chest tightness/shortness of breath (dyspnoea), Exercise induced symptoms. The 4 symptom scores were summed to obtain the asthma symptoms score with range 0(best) to 12(worst). Baseline was set as 8 weeks before randomization as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary.
Outcome measures
| Measure |
PANGRAMIN SLIT HDM MIX
n=400 Participants
Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Placebo
n=200 Participants
Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
|---|---|---|
|
The Change From Baseline in Asthma Symptom Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.
|
-0.36 units on a scale(Symptom score)
Standard Deviation 0.82
|
-0.35 units on a scale(Symptom score)
Standard Deviation 0.75
|
SECONDARY outcome
Timeframe: Total study yearPopulation: The analysis was performed in the Full Analysis Set.
A healthy day is a day without rhinoconjunctivitis symptoms and without any intake of rescue medication. Percentage of healthy days is the healthy days of subject in this study divided by the total study days.
Outcome measures
| Measure |
PANGRAMIN SLIT HDM MIX
n=400 Participants
Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Placebo
n=200 Participants
Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
|---|---|---|
|
Percentage of Healthy Days in This Study Between the Actively Treated Patients and the Placebo Treated.
|
21.92 Percentage of healthy days
Standard Deviation 31.8
|
18.85 Percentage of healthy days
Standard Deviation 30.33
|
SECONDARY outcome
Timeframe: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).Population: The analysis was performed in the Full Analysis Set.
The average rhinoconjunctivitis VAS score (baseline to first year). The scale answers the question 'How have your nasal complaints been today?' from 0 = no symptoms to 10 = severe symptoms. The baseline VAS rhinoconjunctivitis score is the average value of VAS scores in V1 (Screen Visit, Week -8) and V2 (Randomization visit, Week 0), and Evaluation period (Months 11-12) VAS rhinoconjunctivitis score is the average value of VAS scores in V8 (Week 44) and V9 (Week 52).
Outcome measures
| Measure |
PANGRAMIN SLIT HDM MIX
n=400 Participants
Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Placebo
n=200 Participants
Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
|---|---|---|
|
The Change From Baseline in Nasal Complain Scores on Visual Analog Scale at 11-12 Months Between the Actively Treated Patients and the Placebo Treated.
|
-2.45 units on a scale (VAS Score)
Standard Deviation 1.92
|
-2.33 units on a scale (VAS Score)
Standard Deviation 2.13
|
SECONDARY outcome
Timeframe: Visit 1 date(Week -8), Visit 9 date(Week 52).Population: The analysis was performed in the Full Analysis Set.
The baseline RQLQ value was collected in Visit 1 (Week -8) and the 12 months' RQLQ value was collected in Visit 9 (Week 52). The maximum value of RQLQ score is 168 and the minimum one is 0. The score is decreased as the life quality is better.
Outcome measures
| Measure |
PANGRAMIN SLIT HDM MIX
n=400 Participants
Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Placebo
n=200 Participants
Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
|---|---|---|
|
The Change From Baseline in Rhinitis Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.
|
-0.87 units on a scale (RQLQ score)
Standard Deviation 1.07
|
-0.75 units on a scale (RQLQ score)
Standard Deviation 1.01
|
SECONDARY outcome
Timeframe: Visit 9 date, Week 52Population: The analysis was performed in the Full Analysis Set.
Comparing overall rhinoconjunctivitis symptoms at the end of study year Between the Actively Treated Patients and the Placebo Treated.
Outcome measures
| Measure |
PANGRAMIN SLIT HDM MIX
n=400 Participants
Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Placebo
n=200 Participants
Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
|---|---|---|
|
Global Assessment of Rhinoconjunctivitis Symptom After Treatment Between the Actively Treated Patients and the Placebo Treated.
Great
|
72 participants
|
39 participants
|
|
Global Assessment of Rhinoconjunctivitis Symptom After Treatment Between the Actively Treated Patients and the Placebo Treated.
Good
|
213 participants
|
91 participants
|
|
Global Assessment of Rhinoconjunctivitis Symptom After Treatment Between the Actively Treated Patients and the Placebo Treated.
Fair
|
93 participants
|
58 participants
|
|
Global Assessment of Rhinoconjunctivitis Symptom After Treatment Between the Actively Treated Patients and the Placebo Treated.
Worse
|
5 participants
|
3 participants
|
|
Global Assessment of Rhinoconjunctivitis Symptom After Treatment Between the Actively Treated Patients and the Placebo Treated.
Not Done
|
17 participants
|
9 participants
|
SECONDARY outcome
Timeframe: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).Population: The analysis was performed in the Full Analysis Set.
Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their Rhinitis symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores. The scores of all the medication used were summed to produce the daily Rhinitis medication score range from 0 to 30. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome. Baseline was set as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months(8 weeks in count) in evaluation period and divided with the days with diary.
Outcome measures
| Measure |
PANGRAMIN SLIT HDM MIX
n=400 Participants
Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Placebo
n=200 Participants
Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
|---|---|---|
|
The Change From Baseline in Rhinitis Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated.
|
-2.16 units on a scale(Medication score)
Standard Deviation 2.7
|
-2.19 units on a scale(Medication score)
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: Visit 1 date(Week -8), Visit 9 date(Week 52).Population: The analysis was performed in the Full Analysis Set.
The baseline AQLQ value was collected in Visit 1 (Week -8) and the 12 months' RQLQ value was collected in Visit 9 (Week 52). The maximum value of RQLQ score is 217 and the minimum one is 0. The score is elevated as the life quality is better.
Outcome measures
| Measure |
PANGRAMIN SLIT HDM MIX
n=400 Participants
Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Placebo
n=200 Participants
Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
|---|---|---|
|
The Change From Baseline in Asthma Quality of Life Questionnaire at 12 Months Between the Actively Treated Patients and the Placebo Treated.
|
0.33 units on a scale(AQLQ score)
Standard Deviation 0.9
|
0.25 units on a scale(AQLQ score)
Standard Deviation 1.04
|
SECONDARY outcome
Timeframe: Baseline: From V1 date(Week -8) to V2 date(Week 0); 11-12months: From V8 date(Week 44) to V9 date(Week 52).Population: The analysis was performed in the Full Analysis Set.
Subjects were provided with open-labelled rescue medication to be used as needed for treatment of their Asthma symptoms. Subjects reported their use of specific rescue medication via the patient diary cards. Scoring principles were applied to transform the number of rescue medication doses used into medication scores. The scores of all the medication used were summed to produce the daily asthma medication score range from 0 to 32. A lower medication score means the patient use less medication, and represent a better outcome; on the contrary, a higher medication score means the patient use more medication, and represent a worse outcome. Baseline was set as from V1 (Week -8) to V2 (Week 0). 11-12months' end evaluation period was set from V8(Week 44) to V9(Week 52). These two average scores (Baseline and 11-12months) were calculated for each patient as the sum of the daily score throughout the 2 months in evaluation period and divided with the days with diary.
Outcome measures
| Measure |
PANGRAMIN SLIT HDM MIX
n=400 Participants
Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Placebo
n=200 Participants
Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
|---|---|---|
|
The Change From Baseline in Asthma Medication Score at 11 - 12 Months Between the Actively Treated Patients and the Placebo Treated
|
-0.15 units on a scale(Medication score)
Standard Deviation 1.34
|
-0.09 units on a scale(Medication score)
Standard Deviation 0.97
|
Adverse Events
PANGRAMIN SLIT HDM MIX
Placebo
Serious adverse events
| Measure |
PANGRAMIN SLIT HDM MIX
n=402 participants at risk
Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Placebo
n=200 participants at risk
Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute bronchial asthma
|
0.00%
0/402 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
0.50%
1/200 • Number of events 1 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Surgical and medical procedures
Left ureteral calculi
|
0.25%
1/402 • Number of events 1 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
0.00%
0/200 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Infections and infestations
Acute purulent tonsillitis
|
0.25%
1/402 • Number of events 1 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
0.00%
0/200 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Surgical and medical procedures
Deflection of nasal septum
|
0.25%
1/402 • Number of events 1 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
0.00%
0/200 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Surgical and medical procedures
Chronic hypertrophic rhinitis
|
0.25%
1/402 • Number of events 1 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
0.00%
0/200 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid adenoma
|
0.25%
1/402 • Number of events 1 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
0.00%
0/200 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.75%
3/402 • Number of events 3 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
0.50%
1/200 • Number of events 1 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/402 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
0.50%
1/200 • Number of events 1 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
Other adverse events
| Measure |
PANGRAMIN SLIT HDM MIX
n=402 participants at risk
Pangramin SLIT HDM mix.: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
Placebo
n=200 participants at risk
Placebo: Up-dosing phase (vial 0 to vial 4) + maintenance phase (3 times per week), for 12 months.
|
|---|---|---|
|
Infections and infestations
Rhinopharyngitis
|
29.6%
119/402 • Number of events 207 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
26.0%
52/200 • Number of events 107 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Infections and infestations
Upper respiratory tract infection
|
22.4%
90/402 • Number of events 188 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
19.0%
38/200 • Number of events 86 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
11.9%
48/402 • Number of events 64 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
10.5%
21/200 • Number of events 39 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
11.4%
46/402 • Number of events 84 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
10.0%
20/200 • Number of events 35 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Infections and infestations
Bronchitis
|
8.2%
33/402 • Number of events 54 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
10.5%
21/200 • Number of events 30 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
General disorders
Fever
|
6.0%
24/402 • Number of events 34 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
9.0%
18/200 • Number of events 22 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Eye disorders
Eye pruritus
|
5.0%
20/402 • Number of events 24 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
5.5%
11/200 • Number of events 13 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.5%
18/402 • Number of events 61 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
3.0%
6/200 • Number of events 19 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
16/402 • Number of events 25 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
4.5%
9/200 • Number of events 10 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal
|
3.7%
15/402 • Number of events 21 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
3.0%
6/200 • Number of events 8 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Nervous system disorders
Headache
|
3.5%
14/402 • Number of events 16 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
1.0%
2/200 • Number of events 2 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Infections and infestations
Tonsillitis
|
2.7%
11/402 • Number of events 15 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
3.5%
7/200 • Number of events 10 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Skin and subcutaneous tissue disorders
Erythra
|
2.5%
10/402 • Number of events 11 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
2.0%
4/200 • Number of events 7 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
General disorders
Oral hypoesthesia
|
2.2%
9/402 • Number of events 14 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
3.5%
7/200 • Number of events 7 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
General disorders
Chest discomfort
|
2.2%
9/402 • Number of events 14 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
1.0%
2/200 • Number of events 2 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Eye disorders
Conjunctivitis
|
1.2%
5/402 • Number of events 6 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
3.5%
7/200 • Number of events 7 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Gastrointestinal disorders
Dental ulcer
|
2.0%
8/402 • Number of events 10 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
3.0%
6/200 • Number of events 13 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
1.7%
7/402 • Number of events 12 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
2.5%
5/200 • Number of events 6 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Gastrointestinal disorders
Odontalgia
|
1.2%
5/402 • Number of events 6 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
2.5%
5/200 • Number of events 6 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Gastrointestinal disorders
Gastritis
|
0.75%
3/402 • Number of events 3 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
3.0%
6/200 • Number of events 8 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Gastrointestinal disorders
Epigastric pain
|
1.2%
5/402 • Number of events 6 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
2.0%
4/200 • Number of events 10 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.75%
3/402 • Number of events 4 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
2.0%
4/200 • Number of events 4 • All events meeting the definition of an adverse event must be collected and reported from the first trial-related activity after the patient signs the informed consent and until follow up telephone contact. The reporting time frame is almost one year.
The analysis was performed in the Safety Set.
|
Additional Information
Vivian Wang, Sr. Medical Affairs Manager
ALK-Abelló A/S
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor has the right to review and comment any manuscript within 30 days of receipt, but cannot prevent publications of findings. Sponsor will review the communications for accuracy (thus avoiding potential discrepancies with submissions to health authorities), verify that the confidential information is not being inadvertently divulged and provide any relevant supplementary information.
- Publication restrictions are in place
Restriction type: OTHER