Trial Outcomes & Findings for A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071) (NCT NCT00745823)
NCT ID: NCT00745823
Last Updated: 2017-03-21
Results Overview
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
775 participants
Primary outcome timeframe
Week 48
Results posted on
2017-03-21
Participant Flow
Participant milestones
| Measure |
Raltegravir 800 mg q.d.
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
|
Raltegravir 400 mg b.i.d.
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
386
|
389
|
|
Overall Study
TREATED Week 0 - 96
|
382
|
388
|
|
Overall Study
COMPLETED
|
1
|
3
|
|
Overall Study
NOT COMPLETED
|
385
|
386
|
Reasons for withdrawal
| Measure |
Raltegravir 800 mg q.d.
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
|
Raltegravir 400 mg b.i.d.
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
|
|---|---|---|
|
Overall Study
Adverse Event
|
5
|
3
|
|
Overall Study
Lack of Efficacy
|
20
|
6
|
|
Overall Study
Lost to Follow-up
|
10
|
11
|
|
Overall Study
Physician Decision
|
10
|
5
|
|
Overall Study
Pregnancy
|
0
|
4
|
|
Overall Study
Withdrawal by Subject
|
14
|
8
|
|
Overall Study
Study Terminated by Sponsor
|
326
|
349
|
Baseline Characteristics
A Study to Determine the Safety and Efficacy of Once Daily Raltegravir Compared to Twice Daily Raltegravir (MK-0518-071)
Baseline characteristics by cohort
| Measure |
Raltegravir 800 mg q.d.
n=386 Participants
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
|
Raltegravir 400 mg b.i.d.
n=389 Participants
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
|
Total
n=775 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Customized
Between 18 and 64 years
|
382 participants
n=5 Participants
|
382 participants
n=7 Participants
|
764 participants
n=5 Participants
|
|
Age, Customized
>=64 years
|
4 participants
n=5 Participants
|
7 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
318 Participants
n=5 Participants
|
299 Participants
n=7 Participants
|
617 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Data were analyzed for all participants treated with study drug. Participants who did not complete the study were treated as treatment failures.
Outcome measures
| Measure |
Raltegravir 800 mg q.d.
n=382 Participants
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
|
Raltegravir 400 mg b.i.d.
n=386 Participants
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
|
|---|---|---|
|
Number of Participants With HIV Ribonucleic Acid (RNA) <50 Copies/mL at 48 Weeks
|
318 Participants
|
343 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Data were analyzed for all randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Raltegravir 800 mg q.d.
n=382 Participants
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
|
Raltegravir 400 mg b.i.d.
n=388 Participants
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
|
|---|---|---|
|
Number of Participants With One or More Adverse Events at 48 Weeks
|
331 Participants
|
337 Participants
|
PRIMARY outcome
Timeframe: Week 48Population: Data were analyzed for all randomized participants who received at least one dose of study drug.
Outcome measures
| Measure |
Raltegravir 800 mg q.d.
n=382 Participants
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
|
Raltegravir 400 mg b.i.d.
n=388 Participants
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
|
|---|---|---|
|
Number of Participants Who Discontinued Due to an Adverse Event at 48 Weeks
|
4 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Data were analyzed for all participants treated with study drug. Participants who did not complete the study were treated as treatment failures.
Outcome measures
| Measure |
Raltegravir 800 mg q.d.
n=382 Participants
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
|
Raltegravir 400 mg b.i.d.
n=386 Participants
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
|
|---|---|---|
|
Number of Participants With HIV Ribonucleic Acid (RNA) <400 Copies/mL at 48 Weeks
|
338 Participants
|
361 Participants
|
SECONDARY outcome
Timeframe: Baseline and Week 48Population: Data were analyzed for all participants treated with study drug. Baseline values were carried forward for participants who discontinued treatment due to lack of efficacy.
Outcome measures
| Measure |
Raltegravir 800 mg q.d.
n=382 Participants
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
|
Raltegravir 400 mg b.i.d.
n=386 Participants
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
|
|---|---|---|
|
Mean Change From Baseline to Week 48 in CD4 Cell Count
|
209.76 cells/mm^3
Interval 194.6 to 224.9
|
196.20 cells/mm^3
Interval 181.8 to 210.6
|
SECONDARY outcome
Timeframe: Week 96Population: The Week 96 data analysis was not performed.
As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 96Population: The Week 96 data analysis was not performed.
As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline and Week 96Population: The Week 96 data analysis was not performed.
As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 96As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Week 96As the study was terminated after the 48-week analysis, the planned secondary analyses for Week 96 were not performed.
Outcome measures
Outcome data not reported
Adverse Events
Raltegravir 800 mg q.d.
Serious events: 29 serious events
Other events: 287 other events
Deaths: 0 deaths
Raltegravir 400 mg b.i.d.
Serious events: 46 serious events
Other events: 282 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Raltegravir 800 mg q.d.
n=382 participants at risk
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
|
Raltegravir 400 mg b.i.d.
n=388 participants at risk
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Blood and lymphatic system disorders
Lymphadenitis
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Blood and lymphatic system disorders
Retroperitoneal lymphadenopathy
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Cardiac disorders
Atrial fibrillation
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Cardiac disorders
Pericarditis
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Gastrointestinal disorders
Anal fistula
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
General disorders
Chest pain
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
General disorders
Pyrexia
|
0.00%
0/382 • Overall Study
|
1.0%
4/388 • Number of events 4 • Overall Study
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Hepatobiliary disorders
Cholecystitis chronic
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Immune system disorders
Immune reconstitution syndrome
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Infections and infestations
Abscess intestinal
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Infections and infestations
Abscess jaw
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Infections and infestations
Anogenital warts
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Infections and infestations
Appendicitis
|
0.52%
2/382 • Number of events 2 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Infections and infestations
Eye infection syphilitic
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/382 • Overall Study
|
0.52%
2/388 • Number of events 2 • Overall Study
|
|
Infections and infestations
Histoplasmosis
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Infections and infestations
Meningitis aseptic
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Infections and infestations
Meningitis cryptococcal
|
0.26%
1/382 • Number of events 2 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Infections and infestations
Meningitis viral
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Infections and infestations
Mycobacterium avium complex infection
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Infections and infestations
Orchitis
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Infections and infestations
Perirectal abscess
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Infections and infestations
Pneumonia
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Infections and infestations
Pneumonia pneumococcal
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Infections and infestations
Post procedural pneumonia
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Infections and infestations
Sepsis
|
0.00%
0/382 • Overall Study
|
0.52%
2/388 • Number of events 2 • Overall Study
|
|
Infections and infestations
Shigella infection
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Injury, poisoning and procedural complications
Forearm fracture
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Injury, poisoning and procedural complications
Multiple drug overdose
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Injury, poisoning and procedural complications
Penis injury
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Metabolism and nutrition disorders
Obesity
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer stage 0
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.00%
0/382 • Overall Study
|
0.52%
2/388 • Number of events 2 • Overall Study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Burkitt's lymphoma
|
0.00%
0/382 • Overall Study
|
0.52%
2/388 • Number of events 2 • Overall Study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.00%
0/382 • Overall Study
|
0.52%
2/388 • Number of events 2 • Overall Study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma AIDS related
|
0.79%
3/382 • Number of events 3 • Overall Study
|
0.77%
3/388 • Number of events 3 • Overall Study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leiomyoma
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Retroperitoneal neoplasm metastatic
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin cancer
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 2 • Overall Study
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Nervous system disorders
Convulsion
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Nervous system disorders
Transient ischaemic attack
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Psychiatric disorders
Abnormal behaviour
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Psychiatric disorders
Panic attack
|
0.52%
2/382 • Number of events 2 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Psychiatric disorders
Suicide attempt
|
0.26%
1/382 • Number of events 1 • Overall Study
|
1.0%
4/388 • Number of events 4 • Overall Study
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Renal and urinary disorders
Renal colic
|
0.52%
2/382 • Number of events 3 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Renal and urinary disorders
Renal failure acute
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Reproductive system and breast disorders
Amenorrhoea
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Reproductive system and breast disorders
Epididymitis
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Skin and subcutaneous tissue disorders
Hypoaesthesia facial
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 1 • Overall Study
|
|
Vascular disorders
Aortic aneurysm
|
0.26%
1/382 • Number of events 1 • Overall Study
|
0.00%
0/388 • Overall Study
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/382 • Overall Study
|
0.26%
1/388 • Number of events 2 • Overall Study
|
Other adverse events
| Measure |
Raltegravir 800 mg q.d.
n=382 participants at risk
Raltegravir 800 mg by mouth (PO) once daily (q.d.) plus placebo to raltegravir PO twice daily (b.i.d.) plus one tablet of TRUVADA™ for 96 weeks
|
Raltegravir 400 mg b.i.d.
n=388 participants at risk
Raltegravir 400 mg PO b.i.d. plus placebo to raltegravir PO q.d. plus one tablet of TRUVADA™ for 96 weeks
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
5.8%
22/382 • Number of events 23 • Overall Study
|
5.4%
21/388 • Number of events 23 • Overall Study
|
|
Gastrointestinal disorders
Abdominal pain
|
3.4%
13/382 • Number of events 14 • Overall Study
|
5.4%
21/388 • Number of events 27 • Overall Study
|
|
Gastrointestinal disorders
Diarrhoea
|
18.3%
70/382 • Number of events 81 • Overall Study
|
18.0%
70/388 • Number of events 87 • Overall Study
|
|
Gastrointestinal disorders
Nausea
|
10.7%
41/382 • Number of events 47 • Overall Study
|
13.9%
54/388 • Number of events 57 • Overall Study
|
|
Gastrointestinal disorders
Vomiting
|
6.3%
24/382 • Number of events 29 • Overall Study
|
6.4%
25/388 • Number of events 36 • Overall Study
|
|
General disorders
Fatigue
|
6.5%
25/382 • Number of events 28 • Overall Study
|
7.0%
27/388 • Number of events 30 • Overall Study
|
|
General disorders
Pyrexia
|
5.0%
19/382 • Number of events 23 • Overall Study
|
6.7%
26/388 • Number of events 35 • Overall Study
|
|
Infections and infestations
Bronchitis
|
8.1%
31/382 • Number of events 32 • Overall Study
|
7.2%
28/388 • Number of events 34 • Overall Study
|
|
Infections and infestations
Gastroenteritis
|
5.5%
21/382 • Number of events 23 • Overall Study
|
3.6%
14/388 • Number of events 18 • Overall Study
|
|
Infections and infestations
Influenza
|
6.5%
25/382 • Number of events 28 • Overall Study
|
9.3%
36/388 • Number of events 40 • Overall Study
|
|
Infections and infestations
Nasopharyngitis
|
10.5%
40/382 • Number of events 51 • Overall Study
|
13.9%
54/388 • Number of events 70 • Overall Study
|
|
Infections and infestations
Sinusitis
|
4.2%
16/382 • Number of events 17 • Overall Study
|
7.7%
30/388 • Number of events 36 • Overall Study
|
|
Infections and infestations
Upper respiratory tract infection
|
12.8%
49/382 • Number of events 64 • Overall Study
|
13.9%
54/388 • Number of events 70 • Overall Study
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
5.0%
19/382 • Number of events 22 • Overall Study
|
6.4%
25/388 • Number of events 32 • Overall Study
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.0%
23/382 • Number of events 28 • Overall Study
|
5.7%
22/388 • Number of events 25 • Overall Study
|
|
Nervous system disorders
Dizziness
|
9.4%
36/382 • Number of events 39 • Overall Study
|
7.5%
29/388 • Number of events 35 • Overall Study
|
|
Nervous system disorders
Headache
|
15.2%
58/382 • Number of events 70 • Overall Study
|
16.0%
62/388 • Number of events 87 • Overall Study
|
|
Psychiatric disorders
Depression
|
5.8%
22/382 • Number of events 22 • Overall Study
|
5.9%
23/388 • Number of events 25 • Overall Study
|
|
Psychiatric disorders
Insomnia
|
4.7%
18/382 • Number of events 18 • Overall Study
|
5.7%
22/388 • Number of events 22 • Overall Study
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.9%
38/382 • Number of events 40 • Overall Study
|
7.7%
30/388 • Number of events 41 • Overall Study
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
3.9%
15/382 • Number of events 19 • Overall Study
|
5.2%
20/388 • Number of events 23 • Overall Study
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.0%
23/382 • Number of events 26 • Overall Study
|
5.9%
23/388 • Number of events 27 • Overall Study
|
|
Vascular disorders
Hypertension
|
2.9%
11/382 • Number of events 11 • Overall Study
|
5.7%
22/388 • Number of events 22 • Overall Study
|
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Phone: 1- 800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee Twenty-four months after completion of this study or after publication of the multicenter results, an investigator may publish the results for their study site independently. The sponsor must have the opportunity to review all proposed publications or presentations regarding the study 60 days before submission.
- Publication restrictions are in place
Restriction type: OTHER