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A Study to Evaluate the Safety and Efficacy of an Investigational Drug in HIV Infected Patients (0518-004)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00100048
First received: December 22, 2004
Last updated: September 4, 2015
Last verified: September 2015
Results First Received: January 21, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: HIV Infections
Acquired Immunodeficiency Syndrome
Interventions: Drug: Comparator: MK0518 monotherapy
Drug: Comparator: MK0518 combination therapy
Drug: Comparator: efavirenz
Drug: Comparator: tenofovir
Drug: Comparator: lamivudine
Drug: Placebo monotherapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Primary therapy period:

For Part I (10 day monotherapy): 24-Jan-2005 to 04-May-2005

Part II (Dose Ranging): 14-Jun-2005 to 04-Oct-2006 (48 weeks); 14-Jun-2005 to 12-Jul-2010 (240 weeks)

Multicenter (29) in the United States (14) and Ex-US (15)


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

Patients with Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) of at least 5000 copies/mL and cluster of differentiation 4 (CD4) cell counts of at least 100 cells/mm3. All patients must have met laboratory criteria.

206 enrolled; 5 from Cohort I did not continue to the combination phase. Therefore 201 entered the combination phase.


Reporting Groups
  Description
MK0518 100 mg b.i.d.

Cohort I-Monotherapy Phase

MK0518 100 mg twice daily (b.i.d.)

Cohort II Combined-Combination Therapy Phase

MK0518 100 mg + tenofovir + lamivudine

MK0518 200 mg b.i.d

Cohort I-Monotherapy Phase

MK0518 200 mg b.i.d

Cohort II Combined-Combination Therapy Phase

MK0518 200 mg + tenofovir + lamivudine

MK0518 400 mg b.i.d.

Cohort I-Monotherapy Phase

MK0518 400 mg b.i.d.

Cohort II Combined-Combination Therapy Phase

MK0518 400 mg + tenofovir + lamivudine

MK0518 600 mg b.i.d.

Cohort I-Monotherapy Phase

MK0518 600 mg b.i.d.

Cohort II Combined-Combination Therapy Phase

MK0518 600 mg + tenofovir + lamivudine

Placebo

Cohort I-Monotherapy Phase

Placebo to MK0518 b.i.d.

Efavirenz 600 mg q.h.s.

Cohort II Combined-Combination Therapy Phase

efavirenz 600 mg every night at bedtime (q.h.s.)


Participant Flow for 2 periods

Period 1:   Cohort I-Monotherapy Phase 10 Days
    MK0518 100 mg b.i.d.   MK0518 200 mg b.i.d   MK0518 400 mg b.i.d.   MK0518 600 mg b.i.d.   Placebo   Efavirenz 600 mg q.h.s.
STARTED   7   7   6   8   7   0 [1] 
Treated   7   7   6   8   7   0 
COMPLETED   7 [2]   7 [2]   6 [3]   8 [3]   7 [4]   0 
NOT COMPLETED   0   0   0   0   0   0 
[1] participants only assigned Efavirenz 600 mg q.h.s in Cohort II Combined-Combination Therapy Phase
[2] 7 Subjects Continued to Cohort II Combined-Combination Therapy Phase (48 Weeks)
[3] 6 Subjects Continued to Cohort II Combined-Combination Therapy Phase (48 Weeks)
[4] 4 Subjects Continued to Cohort II, as part of the Efavirenz 600 mg q.d. arm

Period 2:   Cohort I & II-Combination Therapy Phase
    MK0518 100 mg b.i.d.   MK0518 200 mg b.i.d   MK0518 400 mg b.i.d.   MK0518 600 mg b.i.d.   Placebo   Efavirenz 600 mg q.h.s.
STARTED   41 [1]   40 [2]   41 [3]   40 [4]   0 [5]   39 [6] 
Treated   39   40   41   40   0   38 
Never Treated   2 [7]   0   0   0   0   1 [7] 
COMPLETED   27   31   28   30   0   26 
NOT COMPLETED   14   9   13   10   0   13 
Never Treated                2                0                0                0                0                1 
Adverse Event                0                1                2                0                0                1 
Lack of Efficacy                1                3                0                0                0                2 
Lost to Follow-up                2                1                3                2                0                3 
Withdrawal by Subject                1                2                2                5                0                4 
Other Reason                7                1                4                2                0                0 
Completed Base Study, Did Not Continue                1                1                2                0                0                2 
Laboratory Adverse Experience                0                0                0                1                0                0 
[1] 7 subjects from the Monotherapy Phase and 34 new subjects
[2] 7 subjects from the Monotherapy Phase and 33 new subjects
[3] 6 subjects from the Monotherapy Phase and 35 new subjects
[4] 8 subjects from the Monotherapy Phase and 32 new subjects
[5] participants only assigned Placebo in Cohort I-Monotherapy Phase.
[6] 4 subjects from the Monotherapy Phase (Placebo)and 35 new subjects
[7] Randomised in Cohort II did not start Period



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
MK0518 100 mg b.i.d.

Cohort I-Monotherapy Phase (10 Days)

MK0518 100 mg twice daily (b.i.d.)

Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 100 mg b.i.d

MK0518 200 mg b.i.d

Cohort I-Monotherapy Phase (10 Days)

MK0518 200 mg b.i.d

Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 200 mg + tenofovir + lamivudine

MK0518 400 mg b.i.d.

Cohort I-Monotherapy Phase (10 Days)

MK0518 400 mg b.i.d.

Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 400 mg + tenofovir + lamivudine

MK0518 600 mg b.i.d.

Cohort I-Monotherapy Phase (10 Days)

MK0518 600 mg b.i.d.

Cohort II Combined-Combination Therapy Phase (48 Weeks) MK0518 600 mg + tenofovir + lamivudine

Placebo / Efavirenz 600 mg Once Daily (q.d.)

Cohort I-Monotherapy Phase (10 Days)

Placebo to MK0518 b.i.d.

Cohort II Combined-Combination Therapy Phase (48 Weeks)

Efavirenz + Tenofovir + Lamivudine

Total Total of all reporting groups

Baseline Measures
   MK0518 100 mg b.i.d.   MK0518 200 mg b.i.d   MK0518 400 mg b.i.d.   MK0518 600 mg b.i.d.   Placebo / Efavirenz 600 mg Once Daily (q.d.)   Total 
Overall Participants Analyzed 
[Units: Participants]
 41   40   41   42   42   206 
Age [1] 
[Units: Years]
Mean (Full Range)
           
Cohort I   46 
 (31 to 68) 
 37 
 (22 to 57) 
 41 
 (25 to 55) 
 39 
 (30 to 49) 
 36 
 (21 to 51) 
 40 
 (21 to 68) 
Cohort II   34 
 (19 to 58) 
 31 
 (21 to 56) 
 34 
 (19 to 50) 
 36 
 (20 to 49) 
 36 
 (22 to 54) 
 35 
 (19 to 58) 
Cohort I & II Combined   37 
 (19 to 68) 
 34 
 (21 to 57) 
 36 
 (19 to 55) 
 37 
 (20 to 49) 
 36 
 (22 to 54) 
 36 
 (19 to 68) 
[1]

Cohort I Participants: MK0518 100 mg b.i.d. (7); MK0518 200 mg b.i.d. (7); MK0518 400 mg b.i.d. (6); MK0518 600 mg b.i.d. (8); Placebo Cohort (7)

Cohort II Participants: MK0518 100 mg b.i.d. (33); MK0518 200 mg b.i.d. (33); MK0518 400 mg b.i.d. (35); MK0518 600 mg b.i.d. (34); Efavirenz 600 mg q.d. (34)

Cohort I & II Participants Combined: MK0518 100 mg b.i.d. (39); MK0518 200 mg b.i.d. (40); MK0518 400 mg b.i.d. (41); MK0518 600 mg b.i.d. (40); Efavirenz 600 mg q.d. (38)

Gender, Customized 
[Units: Participants]
           
Female (Cohort I)   0   1   0   0   1   2 
Male (Cohort I)   7   6   6   8   6   33 
Female (Cohort II)   6   10   4   11   8   39 
Male (Cohort II)   27   23   31   23   26   130 
Never Treated Cohort II   1   0   0   0   1   2 
Race/Ethnicity, Customized 
[Units: Participants]
           
White (Cohort I)   4   4   3   8   3   22 
Black (Cohort I)   1   1   0   0   0   2 
Asian (Cohort I)   0   0   0   0   1   1 
Hispanic (Cohort I)   2   2   3   0   3   10 
White (Cohort II)   4   10   11   8   10   43 
Black (Cohort II)   1   1   1   0   0   3 
Asian (Cohort II)   3   6   8   7   8   32 
Hispanic (Cohort II)   12   9   10   9   10   50 
Other (Cohort II)   13   7   5   10   6   41 
Never Treated (Cohort II)   1   0   0   0   1   2 
Cluster of differentiation 4 (CD4) Cell Count [1] 
[Units: Cells/mm^3]
Mean (Full Range)
           
Cohort I   415 
 (138 to 745) 
 343 
 (149 to 624) 
 256 
 (96 to 602) 
 569 
 (241 to 1034) 
 343 
 (115 to 599) 
 394 
 (96 to 1034) 
Cohort II   293 
 (76 to 736) 
 292 
 (70 to 723) 
 348 
 (95 to 1017) 
 245 
 (99 to 734) 
 276 
 (77 to 744) 
 291 
 (70 to 1017) 
Cohort I and II Combined   272 
 (76 to 758) 
 277 
 (70 to 723) 
 293 
 (95 to 1017) 
 244 
 (99 to 786) 
 225 
 (77 to 744) 
 266 
 (70 to 1017) 
[1] Cohort I Participants: MK0518 100 mg b.i.d. (7); MK0518 200 mg b.i.d. (7); MK0518 400 mg b.i.d. (6); MK0518 600 mg b.i.d. (8); Placebo Cohort (7) Cohort II Participants: MK0518 100 mg b.i.d. (33); MK0518 200 mg b.i.d. (33); MK0518 400 mg b.i.d. (35); MK0518 600 mg b.i.d. (34); Efavirenz 600 mg q.d. (34) Cohort I & II Participants Combined: MK0518 100 mg b.i.d. (39); MK0518 200 mg b.i.d. (40); MK0518 400 mg b.i.d. (41); MK0518 600 mg b.i.d. (40); Efavirenz 600 mg q.d. (38)
Plasma Human Immunodeficiency Virus (HIV) Ribonucleic acid (RNA) [1] 
[Units: copies/mL]
Geometric Mean (Full Range)
           
Cohort I   44989 
 (3890 to 225000) 
 34143 
 (5420 to 168000) 
 37728 
 (6850 to 152000) 
 93911 
 (17100 to 388000) 
 58412 
 (7630 to 456000) 
 51496 
 (3890 to 456000) 
Cohort II   65982 
 (4200 to 750000) 
 73646 
 (7490 to 750000) 
 47019 
 (2440 to 499000) 
 61929 
 (3450 to 750000) 
 76752 
 (7500 to 675000) 
 63965 
 (2440 to 750000) 
Cohort I and II Combined   58206 
 (4200 to 750000) 
 64715 
 (7490 to 750000) 
 43083 
 (2440 to 499000) 
 57919 
 (3450 to 750000) 
 67554 
 (3340 to 675000) 
 57437 
 (2440 to 750000) 
[1] Cohort I Participants: MK0518 100 mg b.i.d. (7); MK0518 200 mg b.i.d. (7); MK0518 400 mg b.i.d. (6); MK0518 600 mg b.i.d. (8); Placebo Cohort (7) Cohort II Participants: MK0518 100 mg b.i.d. (33); MK0518 200 mg b.i.d. (33); MK0518 400 mg b.i.d. (35); MK0518 600 mg b.i.d. (34); Efavirenz 600 mg q.d. (34) Cohort I & II Participants Combined: MK0518 100 mg b.i.d. (39); MK0518 200 mg b.i.d. (40); MK0518 400 mg b.i.d. (41); MK0518 600 mg b.i.d. (40); Efavirenz 600 mg q.d. (38)


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Plasma Human Immunodeficiency Virus (HIV) Ribonucleic Acid (RNA) on Day 10 (Cohort I)   [ Time Frame: Baseline and Day 10 ]

2.  Primary:   Number of Patients With Clinical Adverse Experiences (CAEs) and Number of Patients With Serious CAEs at Day 10 (Cohort I)   [ Time Frame: 10 days ]

3.  Primary:   Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 24 (Cohort II)   [ Time Frame: Week 24 ]

4.  Primary:   Number of Patients With Clinical Adverse Experiences (CAEs)   [ Time Frame: 48 weeks ]

5.  Primary:   Number of Patients With Serious CAEs (Cohort I and II Combined)   [ Time Frame: 48 weeks ]

6.  Primary:   Number of Patients With Serious CAEs and Non-serious CAEs at Week 144   [ Time Frame: 144 Weeks ]

7.  Primary:   Number of Participants With Clinical Adverse Experiences (AEs)and Serious Adverse Experiences (SAEs)   [ Time Frame: Week 240 ]

8.  Primary:   Number of Participants With HIV RNA (Human Immunodeficiency Virus Ribonucleic Acid) Levels Below 50 Copies/mL at Week 240   [ Time Frame: Week 240 ]

9.  Secondary:   Number of Participants With HIV RNA Levels Below 50 Copies/mL at Week 24 (Cohort II)   [ Time Frame: Week 24 ]

10.  Secondary:   Change From Baseline in Plasma HIV RNA at Week 24 (Cohort II)   [ Time Frame: Baseline and Week 24 ]

11.  Secondary:   Change From Baseline in Cluster of Differentiation 4 (CD4) Cell Count at Week 24 (Cohort II)   [ Time Frame: Baseline and Week 24 ]

12.  Secondary:   Number of Patients With HIV RNA Level Below 50 Copies/mL and HIV RNA Level Below 400 Copies/mL at Week 96   [ Time Frame: 96 Weeks ]

13.  Secondary:   Change From Baseline in Plasma HIV RNA at Week 96   [ Time Frame: Baseline and Week 96 ]

14.  Secondary:   Change From Baseline in CD4 Cell Count at Week 96   [ Time Frame: Baseline and Week 96 ]

15.  Secondary:   Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 240   [ Time Frame: Week 240 ]

16.  Secondary:   Change From Baseline in Plasma HIV RNA at Week 240   [ Time Frame: Baseline and Week 240 ]

17.  Secondary:   Change From Baseline in CD4 (T-helper) Cell Count at Week 240   [ Time Frame: Baseline and Week 240 ]

18.  Other Pre-specified:   Number of Participants With HIV RNA Levels Below 400 Copies/mL at Week 48   [ Time Frame: 48 weeks ]

19.  Other Pre-specified:   Number of Patients With Drug-related CAEs   [ Time Frame: 48 weeks ]

20.  Other Pre-specified:   Number of Patients With Serious Drug-related CAEs   [ Time Frame: 48 Weeks ]

21.  Other Pre-specified:   Number of Patients That Discontinued With CAEs   [ Time Frame: 48 Weeks ]

22.  Other Pre-specified:   Number of Patients With Laboratory Adverse Experiences (LAEs)   [ Time Frame: 48 Weeks ]

23.  Other Pre-specified:   Number of Patients With Serious LAEs   [ Time Frame: 48 Weeks ]

24.  Other Pre-specified:   Number of Patients With Drug-related LAEs   [ Time Frame: 48 Weeks ]

25.  Other Pre-specified:   Number of Patients With Serious Drug-related LAEs   [ Time Frame: 48 Weeks ]

26.  Other Pre-specified:   Number of Patients That Discontinued With LAEs   [ Time Frame: 48 Weeks ]


  Serious Adverse Events


  Other Adverse Events
  Hide Other Adverse Events

Time Frame No text entered.
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5  

Reporting Groups
  Description
MK-0518 b.i.d.

Cohort I-Monotherapy Phase (10 Days) MK0518 100, 200, 400, or 600 mg b.i.d.

Cohort II Combined-Combination Therapy Phase MK0518 100, 200, 400, or 600 mg + tenofovir + lamivudine

Efavirenz

EFV Combo Therapy Phase - Cohort II

efavirenz 600 mg daily at bedtime (qhs) + tenofovir + lamivudine

This arm included participants from Cohort I who were randomized to placebo.


Other Adverse Events
    MK-0518 b.i.d.   Efavirenz
Total, other (not including serious) adverse events     
# participants affected / at risk   147/160 (91.88%)   35/38 (92.11%) 
Blood and lymphatic system disorders     
Anaemia † 1     
# participants affected / at risk   1/160 (0.63%)   2/38 (5.26%) 
# events   1   2 
Lymphadenopathy † 1     
# participants affected / at risk   2/160 (1.25%)   2/38 (5.26%) 
# events   3   2 
Eye disorders     
Conjunctivitis † 1     
# participants affected / at risk   7/160 (4.38%)   3/38 (7.89%) 
# events   8   3 
Gastrointestinal disorders     
Abdominal pain † 1     
# participants affected / at risk   10/160 (6.25%)   2/38 (5.26%) 
# events   11   2 
Anorectal discomfort † 1     
# participants affected / at risk   0/160 (0.00%)   2/38 (5.26%) 
# events   0   2 
Constipation † 1     
# participants affected / at risk   4/160 (2.50%)   2/38 (5.26%) 
# events   5   2 
Diarrhoea † 1     
# participants affected / at risk   42/160 (26.25%)   10/38 (26.32%) 
# events   67   19 
Flatulence † 1     
# participants affected / at risk   11/160 (6.88%)   1/38 (2.63%) 
# events   12   1 
Gastritis † 1     
# participants affected / at risk   7/160 (4.38%)   4/38 (10.53%) 
# events   8   4 
Nausea † 1     
# participants affected / at risk   35/160 (21.88%)   7/38 (18.42%) 
# events   40   8 
Toothache † 1     
# participants affected / at risk   9/160 (5.63%)   1/38 (2.63%) 
# events   10   1 
Vomiting † 1     
# participants affected / at risk   13/160 (8.13%)   7/38 (18.42%) 
# events   20   9 
General disorders     
Fatigue † 1     
# participants affected / at risk   13/160 (8.13%)   3/38 (7.89%) 
# events   17   4 
Influenza like illness † 1     
# participants affected / at risk   11/160 (6.88%)   3/38 (7.89%) 
# events   14   3 
Malaise † 1     
# participants affected / at risk   5/160 (3.13%)   3/38 (7.89%) 
# events   10   6 
Oedema peripheral † 1     
# participants affected / at risk   3/160 (1.88%)   2/38 (5.26%) 
# events   3   2 
Pyrexia † 1     
# participants affected / at risk   12/160 (7.50%)   2/38 (5.26%) 
# events   16   2 
Infections and infestations     
Anogenital warts † 1     
# participants affected / at risk   4/160 (2.50%)   3/38 (7.89%) 
# events   4   4 
Body tinea † 1     
# participants affected / at risk   6/160 (3.75%)   3/38 (7.89%) 
# events   7   5 
Bronchitis † 1     
# participants affected / at risk   23/160 (14.37%)   2/38 (5.26%) 
# events   31   3 
Gastroenteritis † 1     
# participants affected / at risk   7/160 (4.38%)   2/38 (5.26%) 
# events   10   7 
Herpes simplex † 1     
# participants affected / at risk   10/160 (6.25%)   0/38 (0.00%) 
# events   12   0 
Herpes zoster † 1     
# participants affected / at risk   9/160 (5.63%)   6/38 (15.79%) 
# events   9   6 
Influenza † 1     
# participants affected / at risk   3/160 (1.88%)   4/38 (10.53%) 
# events   3   6 
Localised infection † 1     
# participants affected / at risk   1/160 (0.63%)   2/38 (5.26%) 
# events   1   2 
Nasopharyngitis † 1     
# participants affected / at risk   30/160 (18.75%)   8/38 (21.05%) 
# events   57   13 
Onychomycosis † 1     
# participants affected / at risk   5/160 (3.13%)   4/38 (10.53%) 
# events   7   5 
Pharyngitis † 1     
# participants affected / at risk   19/160 (11.88%)   2/38 (5.26%) 
# events   21   3 
Sinusitis † 1     
# participants affected / at risk   16/160 (10.00%)   2/38 (5.26%) 
# events   19   5 
Syphilis † 1     
# participants affected / at risk   9/160 (5.63%)   3/38 (7.89%) 
# events   10   3 
Upper respiratory tract infection † 1     
# participants affected / at risk   39/160 (24.38%)   10/38 (26.32%) 
# events   74   13 
Injury, poisoning and procedural complications     
Joint sprain † 1     
# participants affected / at risk   3/160 (1.88%)   2/38 (5.26%) 
# events   3   2 
Investigations     
Alanine aminotransferase increased † 1     
# participants affected / at risk   13/160 (8.13%)   4/38 (10.53%) 
# events   29   10 
Aspartate aminotransferase increased † 1     
# participants affected / at risk   14/160 (8.75%)   6/38 (15.79%) 
# events   19   7 
Blood creatine phosphokinase increased † 1     
# participants affected / at risk   8/160 (5.00%)   4/38 (10.53%) 
# events   12   5 
Blood triglycerides increased † 1     
# participants affected / at risk   4/160 (2.50%)   2/38 (5.26%) 
# events   8   5 
Weight decreased † 1     
# participants affected / at risk   3/160 (1.88%)   2/38 (5.26%) 
# events   3   2 
Metabolism and nutrition disorders     
Overweight † 1     
# participants affected / at risk   9/160 (5.63%)   1/38 (2.63%) 
# events   10   1 
Musculoskeletal and connective tissue disorders     
Arthralgia † 1     
# participants affected / at risk   14/160 (8.75%)   1/38 (2.63%) 
# events   17   1 
Back pain † 1     
# participants affected / at risk   22/160 (13.75%)   2/38 (5.26%) 
# events   23   2 
Myalgia † 1     
# participants affected / at risk   7/160 (4.38%)   3/38 (7.89%) 
# events   7   3 
Pain in extremity † 1     
# participants affected / at risk   8/160 (5.00%)   3/38 (7.89%) 
# events   10   4 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Skin papilloma † 1     
# participants affected / at risk   8/160 (5.00%)   2/38 (5.26%) 
# events   9   3 
Nervous system disorders     
Disturbance in attention † 1     
# participants affected / at risk   4/160 (2.50%)   2/38 (5.26%) 
# events   4   2 
Dizziness † 1     
# participants affected / at risk   29/160 (18.13%)   13/38 (34.21%) 
# events   33   15 
Headache † 1     
# participants affected / at risk   33/160 (20.63%)   16/38 (42.11%) 
# events   56   31 
Lethargy † 1     
# participants affected / at risk   3/160 (1.88%)   2/38 (5.26%) 
# events   3   2 
Psychiatric disorders     
Abnormal dreams † 1     
# participants affected / at risk   13/160 (8.13%)   8/38 (21.05%) 
# events   13   9 
Anxiety † 1     
# participants affected / at risk   10/160 (6.25%)   4/38 (10.53%) 
# events   11   4 
Depression † 1     
# participants affected / at risk   20/160 (12.50%)   5/38 (13.16%) 
# events   23   6 
Insomnia † 1     
# participants affected / at risk   25/160 (15.63%)   5/38 (13.16%) 
# events   29   5 
Nightmare † 1     
# participants affected / at risk   1/160 (0.63%)   4/38 (10.53%) 
# events   1   4 
Respiratory, thoracic and mediastinal disorders     
Asthma † 1     
# participants affected / at risk   3/160 (1.88%)   2/38 (5.26%) 
# events   6   2 
Cough † 1     
# participants affected / at risk   8/160 (5.00%)   2/38 (5.26%) 
# events   10   2 
Nasal congestion † 1     
# participants affected / at risk   3/160 (1.88%)   2/38 (5.26%) 
# events   3   2 
Oropharyngeal pain † 1     
# participants affected / at risk   7/160 (4.38%)   3/38 (7.89%) 
# events   7   3 
Skin and subcutaneous tissue disorders     
Dermatitis † 1     
# participants affected / at risk   9/160 (5.63%)   2/38 (5.26%) 
# events   9   3 
Pruritus † 1     
# participants affected / at risk   12/160 (7.50%)   2/38 (5.26%) 
# events   14   3 
Rash † 1     
# participants affected / at risk   11/160 (6.88%)   2/38 (5.26%) 
# events   14   2 
Rash papular † 1     
# participants affected / at risk   0/160 (0.00%)   3/38 (7.89%) 
# events   0   3 
Seborrhoeic dermatitis † 1     
# participants affected / at risk   3/160 (1.88%)   2/38 (5.26%) 
# events   6   2 
Skin lesion † 1     
# participants affected / at risk   8/160 (5.00%)   3/38 (7.89%) 
# events   11   3 
Urticaria † 1     
# participants affected / at risk   2/160 (1.25%)   2/38 (5.26%) 
# events   2   2 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 13.0



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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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