Trial Outcomes & Findings for Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607) (NCT NCT01700192)
NCT ID: NCT01700192
Last Updated: 2017-09-15
Results Overview
The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1482 participants
Primary outcome timeframe
Last 8 weeks of treatment (Weeks 44 to 52)
Results posted on
2017-09-15
Participant Flow
Participant milestones
| Measure |
MK-8237
Participants took MK-8237 12 development unit (DU) rapidly dissolving tablets administered sublingually once daily (q.d.) for up to one year.
|
Placebo
Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
|---|---|---|
|
Overall Study
STARTED
|
741
|
741
|
|
Overall Study
Treated
|
740
|
741
|
|
Overall Study
All Participants as Treated (APaT)
|
743
|
738
|
|
Overall Study
COMPLETED
|
561
|
613
|
|
Overall Study
NOT COMPLETED
|
180
|
128
|
Reasons for withdrawal
| Measure |
MK-8237
Participants took MK-8237 12 development unit (DU) rapidly dissolving tablets administered sublingually once daily (q.d.) for up to one year.
|
Placebo
Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
|---|---|---|
|
Overall Study
Adverse Event
|
73
|
18
|
|
Overall Study
Lack of Efficacy
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
42
|
29
|
|
Overall Study
Noncompliance with study drug
|
0
|
5
|
|
Overall Study
Physician Decision
|
2
|
3
|
|
Overall Study
Pregnancy
|
1
|
4
|
|
Overall Study
Progressive disease
|
1
|
0
|
|
Overall Study
Protocol Violation
|
3
|
4
|
|
Overall Study
Technical problems
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
56
|
64
|
|
Overall Study
Never received study drug
|
1
|
0
|
Baseline Characteristics
Efficacy and Safety Study of SCH 900237/MK-8237 in Children and Adults With House Dust Mite-Induced Allergic Rhinitis/Rhinoconjunctivitis (P05607)
Baseline characteristics by cohort
| Measure |
MK-8237
n=741 Participants
Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
Placebo
n=741 Participants
Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
Total
n=1482 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
34.9 Years
STANDARD_DEVIATION 13.82 • n=99 Participants
|
35.2 Years
STANDARD_DEVIATION 13.74 • n=107 Participants
|
35.1 Years
STANDARD_DEVIATION 13.77 • n=206 Participants
|
|
Sex: Female, Male
Female
|
445 Participants
n=99 Participants
|
430 Participants
n=107 Participants
|
875 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
296 Participants
n=99 Participants
|
311 Participants
n=107 Participants
|
607 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)Population: The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.
The TCRS is the sum of the rhinitis Daily Symptom Score (DSS; range: 0 to 12) and the rhinitis Daily Medication Score (DMS; range: 0 to 12); the total possible TCRS ranges from 0 to 24 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Outcome measures
| Measure |
MK-8237
n=566 Participants
Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
Placebo
n=620 Participants
Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
|---|---|---|
|
Average Total Combined Rhinitis Score (TCRS) During Last 8 Weeks of Treatment
|
4.67 Score on a Scale
Standard Deviation 3.55
|
5.49 Score on a Scale
Standard Deviation 3.82
|
PRIMARY outcome
Timeframe: Up to 54 weeksPopulation: The All Participants as Treated (APaT) population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
MK-8237
n=743 Participants
Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
Placebo
n=738 Participants
Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
|---|---|---|
|
Number of Participants Who Experience At Least One Adverse Event (AE)
|
676 Participants
|
539 Participants
|
PRIMARY outcome
Timeframe: Up to 52 weeksPopulation: The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
An AE is defined as any untoward medical occurrence in a clinical investigation participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment.
Outcome measures
| Measure |
MK-8237
n=743 Participants
Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
Placebo
n=738 Participants
Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
|---|---|---|
|
Number of Participants Who Discontinue Study Drug Due to an AE
|
73 Participants
|
19 Participants
|
SECONDARY outcome
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)Population: The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.
The Rhinitis DSS ranges from a score of 0 to 12 (higher scores indicative of greater symptom severity). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Outcome measures
| Measure |
MK-8237
n=566 Participants
Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
Placebo
n=620 Participants
Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
|---|---|---|
|
Average Rhinitis Daily Symptom Score (Rhinitis DSS) During Last 8 Weeks of Treatment
|
3.83 Score on a Scale
Standard Deviation 2.64
|
4.46 Score on a Scale
Standard Deviation 2.80
|
SECONDARY outcome
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)Population: The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.
The Rhinitis DMS ranges from a score of 0 to 12 (higher scores indicative of greater symptomatic medication use). The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Outcome measures
| Measure |
MK-8237
n=566 Participants
Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
Placebo
n=620 Participants
Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
|---|---|---|
|
Average Rhinitis Daily Medication Score (Rhinitis DMS) During Last 8 Weeks of Treatment
|
0.84 Score on a Scale
Standard Deviation 1.817
|
1.03 Score on a Scale
Standard Deviation 2.074
|
SECONDARY outcome
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)Population: The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.
The TCS is the sum of the rhinoconjunctivitis DSS (rhinitis DSS and conjunctivitis DSS; range: 0 to 18) and the rhinoconjunctivitis DMS (rhinitis DMS and conjunctivitis DMS; range: 0 to 20); the total possible TCS ranges from 0 to 38 points with higher scores indicative of greater symptom severity. The endpoint was calculated as the average daily diary entry score from the last 8 weeks of treatment.
Outcome measures
| Measure |
MK-8237
n=566 Participants
Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
Placebo
n=620 Participants
Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
|---|---|---|
|
Average Total Combined Rhinoconjunctivitis Score (TCS) During Last 8 Weeks of Treatment
|
6.40 Score on a Scale
Standard Deviation 5.16
|
7.62 Score on a Scale
Standard Deviation 5.48
|
SECONDARY outcome
Timeframe: Last 8 weeks of treatment (Weeks 44 to 52)Population: The analysis population consists of all randomized participants who received at least 1 dose of study drug and had data available.
Participants indicated the severity of symptoms in the past week on a VAS with a score range of 0 ("no symptoms") to 100 ("severe symptoms"). Symptoms were assessed during 2 clinic visits occurring during the final 8 weeks of treatment (VAS score reflects the mean of 2 scores).
Outcome measures
| Measure |
MK-8237
n=540 Participants
Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
Placebo
n=585 Participants
Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
|---|---|---|
|
Average Allergic Rhinitis/Rhinoconjunctivitis Symptoms Assessed by Visual Analogue Scale (VAS) During Last 8 Weeks of Treatment
|
42.29 Score on a Scale
Standard Deviation 23.57
|
47.96 Score on a Scale
Standard Deviation 23.66
|
Adverse Events
MK-8237 12 DU
Serious events: 11 serious events
Other events: 642 other events
Deaths: 0 deaths
Placebo
Serious events: 7 serious events
Other events: 389 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MK-8237 12 DU
n=743 participants at risk
Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
Placebo
n=738 participants at risk
Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
|---|---|---|
|
Cardiac disorders
Pericarditis
|
0.13%
1/743 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.00%
0/738 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.13%
1/743 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.00%
0/738 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Gastrointestinal disorders
Oral pain
|
0.13%
1/743 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.00%
0/738 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Gastrointestinal disorders
Oral pruritus
|
0.13%
1/743 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.00%
0/738 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.00%
0/743 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.14%
1/738 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/743 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.14%
1/738 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Immune system disorders
Anaphylactic reaction
|
0.00%
0/743 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.14%
1/738 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Immune system disorders
Food allergy
|
0.00%
0/743 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.14%
1/738 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Infections and infestations
Diverticulitis
|
0.13%
1/743 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.00%
0/738 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Infections and infestations
Infected bites
|
0.13%
1/743 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.00%
0/738 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Infections and infestations
Peritonitis
|
0.13%
1/743 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.00%
0/738 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Injury, poisoning and procedural complications
Concussion
|
0.13%
1/743 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.00%
0/738 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.13%
1/743 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.00%
0/738 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.00%
0/743 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.14%
1/738 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.13%
1/743 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.00%
0/738 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Psychiatric disorders
Bipolar I disorder
|
0.00%
0/743 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.14%
1/738 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Psychiatric disorders
Depression
|
0.00%
0/743 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.14%
1/738 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Renal and urinary disorders
Calculus ureteric
|
0.13%
1/743 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.00%
0/738 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.13%
1/743 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.00%
0/738 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Vascular disorders
Deep vein thrombosis
|
0.13%
1/743 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.00%
0/738 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Vascular disorders
Hypertensive emergency
|
0.13%
1/743 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.00%
0/738 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Psychiatric disorders
Alcohol abuse
|
0.13%
1/743 • Number of events 1 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
0.00%
0/738 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
Other adverse events
| Measure |
MK-8237 12 DU
n=743 participants at risk
Participants took MK-8237 12 DU rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
Placebo
n=738 participants at risk
Participants took placebo to MK-8237 rapidly dissolving tablets administered sublingually q.d. for up to one year.
|
|---|---|---|
|
Ear and labyrinth disorders
Ear pruritus
|
51.4%
382/743 • Number of events 1637 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
12.5%
92/738 • Number of events 244 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Gastrointestinal disorders
Abdominal pain upper
|
12.4%
92/743 • Number of events 212 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
6.0%
44/738 • Number of events 87 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Gastrointestinal disorders
Diarrhoea
|
7.4%
55/743 • Number of events 85 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
3.7%
27/738 • Number of events 42 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Gastrointestinal disorders
Glossodynia
|
16.0%
119/743 • Number of events 296 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
3.5%
26/738 • Number of events 58 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Gastrointestinal disorders
Lip swelling
|
18.8%
140/743 • Number of events 353 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
2.6%
19/738 • Number of events 42 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Gastrointestinal disorders
Mouth swelling
|
9.8%
73/743 • Number of events 165 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
1.6%
12/738 • Number of events 32 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Gastrointestinal disorders
Mouth ulceration
|
11.4%
85/743 • Number of events 196 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
3.7%
27/738 • Number of events 41 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Gastrointestinal disorders
Nausea
|
16.3%
121/743 • Number of events 293 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
7.7%
57/738 • Number of events 111 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Gastrointestinal disorders
Oral pruritus
|
63.0%
468/743 • Number of events 1966 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
14.8%
109/738 • Number of events 277 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Gastrointestinal disorders
Palatal swelling
|
11.0%
82/743 • Number of events 183 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
1.5%
11/738 • Number of events 14 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Gastrointestinal disorders
Paraesthesia oral
|
9.6%
71/743 • Number of events 173 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
2.8%
21/738 • Number of events 28 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Gastrointestinal disorders
Swollen tongue
|
16.6%
123/743 • Number of events 255 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
2.3%
17/738 • Number of events 31 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Gastrointestinal disorders
Tongue ulceration
|
12.9%
96/743 • Number of events 232 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
2.8%
21/738 • Number of events 29 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Infections and infestations
Nasopharyngitis
|
8.3%
62/743 • Number of events 81 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
8.3%
61/738 • Number of events 68 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Infections and infestations
Upper respiratory tract infection
|
8.5%
63/743 • Number of events 76 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
10.0%
74/738 • Number of events 87 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Nervous system disorders
Dysgeusia
|
9.8%
73/743 • Number of events 143 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
3.9%
29/738 • Number of events 48 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Nervous system disorders
Headache
|
4.7%
35/743 • Number of events 43 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
6.4%
47/738 • Number of events 63 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
14.7%
109/743 • Number of events 268 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
3.1%
23/738 • Number of events 40 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
68.1%
506/743 • Number of events 2144 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
23.3%
172/738 • Number of events 505 • Up to 54 weeks
The APaT population consists of all randomized participants who received at least 1 dose of study drug (data presented according to actual treatment received).
|
Additional Information
Senior Vice President, Global Corporate Development
Merck Sharp & Dohme Corp.
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor must have the opportunity to review all proposed abstracts, manuscripts or presentations regarding this trial 45 days prior to submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER