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A Dose Ranging Trial of GSK1349572 and 2 NRTI in HIV-1 Infected, Therapy Naive Subjects (ING112276)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2013 by ViiV Healthcare.
Recruitment status was:  Active, not recruiting
Sponsor:
Collaborators:
Shionogi
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare
ClinicalTrials.gov Identifier:
NCT00951015
First received: July 30, 2009
Last updated: December 19, 2013
Last verified: October 2013
Results First Received: August 22, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Infection, Human Immunodeficiency Virus
Interventions: Drug: GSK1349572
Drug: efavirenz

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible participants (par.) were randomized (ran) to receive Dolutegravir (DTG) (3 dose groups) or Efavirenz for 96 weeks. At Week 96, par. ran. to any dose of DTG entered an open-label phase and continued to receive DTG at the selected dose of 50 milligrams. A total of 208 par. were ran., and 205 received at least one dose of study medication.

Reporting Groups
  Description
DTG 10 mg OD Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (OD) for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Participant Flow:   Overall Study
    DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD
STARTED   53   51   51   50 
Ongoing   47   45   46   8 
COMPLETED   0   0   0   32 
NOT COMPLETED   53   51   51   18 
Adverse Event                1                1                2                5 
Lack of Efficacy                1                1                0                0 
Protocol Violation                1                1                1                0 
Protocol-Defined Stopping Criteria                0                0                0                1 
Lost to Follow-up                0                2                1                2 
Withdrawal by Subject                3                1                1                2 
Ongoing                47                45                46                8 



  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
DTG 10 mg OD Participants received Dolutegravir (DTG) 10 milligrams (mg), DTG matching placebo, and Abacavir (ABC)/Lamivudine (3TC) 600 mg/300 mg or Tenofovir (TDF)/Emtricitabine (FTC) 300 mg/200 mg orally once daily (OD) for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.
Total Total of all reporting groups

Baseline Measures
   DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD   Total 
Overall Participants Analyzed 
[Units: Participants]
 53   51   51   50   205 
Age 
[Units: Years]
Mean (Standard Deviation)
 34.2  (9.25)   37.0  (9.79)   37.0  (8.89)   40.7  (11.19)   37.2  (10.00) 
Gender 
[Units: Participants]
         
Female   11   5   6   6   28 
Male   42   46   45   44   177 
Race/Ethnicity, Customized 
[Units: Participants]
         
African American/African Heritage (HER)   7   6   8   4   25 
American Indian or Alaska Native   1   3   4   2   10 
Japanese/East Asian HER/South East Asian HER   0   0   0   1   1 
Native Hawaiian or other Pacific Islander   3   0   0   0   3 
White   41   42   38   43   164 
African American/African HER & White   0   0   1   0   1 
Asian & White   1   0   0   0   1 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Participants With Human Immunodeficiency Virus Type 1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 16   [ Time Frame: Week 16 ]

2.  Secondary:   Viral Change Over the Initial 2 Weeks of Treatment   [ Time Frame: Baseline and Week 2 ]

3.  Secondary:   Change From Baseline in HIV-1 RNA at the Indicated Time Points   [ Time Frame: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96 ]

4.  Secondary:   Change From Baseline in Cluster of Differentiation 4+ (CD4+) Cell Counts at the Indicated Time Points   [ Time Frame: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96 ]

5.  Secondary:   Number of Participants With New HIV-associated Conditions of the Indicated Class   [ Time Frame: From Baseline up to Week 96 ]

6.  Secondary:   Number of Participants With the Indicated Type of HIV-1 Disease Progression (AIDS or Death)   [ Time Frame: From Baseline up to Week 96 ]

7.  Secondary:   Number of Participants With Plasma HIV-1 RNA <50 c/mL   [ Time Frame: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96 ]

8.  Secondary:   Number of Participants With Plasma HIV-1 RNA <400 c/mL   [ Time Frame: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96 ]

9.  Secondary:   Number of Participants With Any Adverse Event (AE) and Any Serious Adverse Events (SAE)   [ Time Frame: From Baseline up to Week 96/Early Withdrawal ]

10.  Secondary:   Number of Participants With the Indicated Grade 1 to Grade 4 Treatment-emergent Clinical Chemistry and Hematology Toxicities   [ Time Frame: From Baseline up to Week 96/Early Withdrawal ]

11.  Secondary:   Number of Participants With the Indicated Treatment-emergent Integrase (IN) Mutations Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance   [ Time Frame: From Baseline up to Week 96/Early Withdrawal ]

12.  Secondary:   Number of Participants With the Indicated Treatment-emergent Major Mutations of Other Classes Detected at the Time of Protocol-defined Virologic Failure (PDVF), as a Measure of Genotypic Resistance   [ Time Frame: From Baseline up to Week 96/Early Withdrawal ]

13.  Secondary:   Number of Participants With the Indicated Fold Increase in DTG FC (Fold Change in IC50 Relative to Wild-type Virus) at the Time of PDVF, as a Measure of Post-Baseline Phenotypic Resistance   [ Time Frame: From Baseline up to Week 96/Early Withdrawal ]

14.  Secondary:   Plasma DTG Concentration   [ Time Frame: Week 2, Week 12, and Week 24 ]

15.  Secondary:   AUC(0-tau) of DTG   [ Time Frame: pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2 ]

16.  Secondary:   Cmax, Cmin, and Ctau of DTG   [ Time Frame: pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2 ]

17.  Secondary:   C0 and C0 Avg of DTG   [ Time Frame: Week 2, Week 12, and Week 24 ]

18.  Secondary:   Time to Maximal Drug Concentration (Tmax) of DTG   [ Time Frame: pre-dose and 2, 3, 4, 8, and 24 hours post-dose at Week 2 ]

19.  Secondary:   Relationship Between the Change From Baseline in Plasma HIV-1 RNA at Week 2 and the Indicated Plasma DTG PK Parameters   [ Time Frame: Week 2 ]

20.  Secondary:   Relationship Between the Change From Baseline in CD4+ Cell Counts at Week 96 and the Indicated Plasma DTG PK Parameters   [ Time Frame: Week 96 ]

21.  Secondary:   Relationship Between the Indicated Safety Parameters at Week 96 and the Indicated Plasma DTG PK Parameters   [ Time Frame: Week 96 ]

22.  Secondary:   Relationship Between Gastrointestinal System Organ Class AEs of Special Interest at Week 96 and the Indicated Plasma DTG PK Parameters   [ Time Frame: Week 96 ]

23.  Other Pre-specified:   Change From Baseline in Cluster of Differentiation 8+ (CD8+) Cell Counts at the Indicated Time Points   [ Time Frame: Baseline (Day 1), Week 1, Week 2, Week 4, Week 8, Week 12, Week 16, Week 20, Week 24, Week 32, Week 40, Week 48, Week 60, Week 72, Week 84, and Week 96 ]


  Serious Adverse Events


  Other Adverse Events
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Time Frame Serious adverse events (SAEs) and non-serious AEs were collected in the time period from Baseline up to Week 96/Early Withdrawal.
Additional Description SAEs and AEs were collected in members of Safety Population, comprised of all participants who received at least one dose of study medication.

Frequency Threshold
Threshold above which other adverse events are reported   3  

Reporting Groups
  Description
DTG 10 mg OD Participants received DTG 10 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 25 mg OD Participants received DTG 25 mg, DTG matching placebo, and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
DTG 50 mg OD Participants received DTG 50 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks. Following Week 96, participants continued to receive DTG 50 mg OD.
EFV 600 mg OD Participants received Efavirenz (EFV) 600 mg and ABC/3TC 600 mg/300 mg or TDF/FTC 300 mg/200 mg orally OD for 96 weeks.

Other Adverse Events
    DTG 10 mg OD   DTG 25 mg OD   DTG 50 mg OD   EFV 600 mg OD
Total, other (not including serious) adverse events         
# participants affected / at risk   45/53 (84.91%)   40/51 (78.43%)   43/51 (84.31%)   41/50 (82.00%) 
Blood and lymphatic system disorders         
Lymphadenopathy † 1         
# participants affected / at risk   2/53 (3.77%)   3/51 (5.88%)   0/51 (0.00%)   0/50 (0.00%) 
Ear and labyrinth disorders         
Vertigo † 1         
# participants affected / at risk   2/53 (3.77%)   1/51 (1.96%)   2/51 (3.92%)   2/50 (4.00%) 
Ear pain † 1         
# participants affected / at risk   0/53 (0.00%)   2/51 (3.92%)   0/51 (0.00%)   1/50 (2.00%) 
Endocrine disorders         
Hypogonadism † 1         
# participants affected / at risk   2/53 (3.77%)   0/51 (0.00%)   1/51 (1.96%)   0/50 (0.00%) 
Eye disorders         
Conjunctivitis † 1         
# participants affected / at risk   0/53 (0.00%)   2/51 (3.92%)   2/51 (3.92%)   0/50 (0.00%) 
Gastrointestinal disorders         
Diarrhoea † 1         
# participants affected / at risk   7/53 (13.21%)   9/51 (17.65%)   9/51 (17.65%)   7/50 (14.00%) 
Nausea † 1         
# participants affected / at risk   10/53 (18.87%)   7/51 (13.73%)   6/51 (11.76%)   6/50 (12.00%) 
Abdominal pain upper † 1         
# participants affected / at risk   4/53 (7.55%)   3/51 (5.88%)   1/51 (1.96%)   1/50 (2.00%) 
Abdominal pain † 1         
# participants affected / at risk   3/53 (5.66%)   1/51 (1.96%)   2/51 (3.92%)   1/50 (2.00%) 
Vomiting † 1         
# participants affected / at risk   3/53 (5.66%)   3/51 (5.88%)   0/51 (0.00%)   1/50 (2.00%) 
Dyspepsia † 1         
# participants affected / at risk   0/53 (0.00%)   2/51 (3.92%)   2/51 (3.92%)   2/50 (4.00%) 
Abdominal discomfort † 1         
# participants affected / at risk   2/53 (3.77%)   1/51 (1.96%)   1/51 (1.96%)   1/50 (2.00%) 
Toothache † 1         
# participants affected / at risk   2/53 (3.77%)   1/51 (1.96%)   1/51 (1.96%)   1/50 (2.00%) 
Constipation † 1         
# participants affected / at risk   3/53 (5.66%)   1/51 (1.96%)   0/51 (0.00%)   0/50 (0.00%) 
Haemorrhoids † 1         
# participants affected / at risk   0/53 (0.00%)   0/51 (0.00%)   2/51 (3.92%)   2/50 (4.00%) 
General disorders         
Fatigue † 1         
# participants affected / at risk   3/53 (5.66%)   3/51 (5.88%)   2/51 (3.92%)   6/50 (12.00%) 
Pyrexia † 1         
# participants affected / at risk   5/53 (9.43%)   4/51 (7.84%)   1/51 (1.96%)   4/50 (8.00%) 
Asthenia † 1         
# participants affected / at risk   4/53 (7.55%)   3/51 (5.88%)   1/51 (1.96%)   0/50 (0.00%) 
Chest pain † 1         
# participants affected / at risk   1/53 (1.89%)   1/51 (1.96%)   0/51 (0.00%)   2/50 (4.00%) 
Influenza like illness † 1         
# participants affected / at risk   1/53 (1.89%)   0/51 (0.00%)   2/51 (3.92%)   1/50 (2.00%) 
Immune system disorders         
Seasonal allergy † 1         
# participants affected / at risk   1/53 (1.89%)   2/51 (3.92%)   1/51 (1.96%)   0/50 (0.00%) 
Infections and infestations         
Nasopharyngitis † 1         
# participants affected / at risk   8/53 (15.09%)   8/51 (15.69%)   6/51 (11.76%)   5/50 (10.00%) 
Influenza † 1         
# participants affected / at risk   5/53 (9.43%)   5/51 (9.80%)   4/51 (7.84%)   3/50 (6.00%) 
Bronchitis † 1         
# participants affected / at risk   5/53 (9.43%)   2/51 (3.92%)   2/51 (3.92%)   5/50 (10.00%) 
Upper respiratory tract infection † 1         
# participants affected / at risk   2/53 (3.77%)   3/51 (5.88%)   6/51 (11.76%)   1/50 (2.00%) 
Sinusitis † 1         
# participants affected / at risk   2/53 (3.77%)   2/51 (3.92%)   3/51 (5.88%)   4/50 (8.00%) 
Respiratory tract infection † 1         
# participants affected / at risk   4/53 (7.55%)   1/51 (1.96%)   2/51 (3.92%)   3/50 (6.00%) 
Pharyngitis † 1         
# participants affected / at risk   3/53 (5.66%)   3/51 (5.88%)   1/51 (1.96%)   2/50 (4.00%) 
Syphilis † 1         
# participants affected / at risk   1/53 (1.89%)   3/51 (5.88%)   1/51 (1.96%)   4/50 (8.00%) 
Oral herpes † 1         
# participants affected / at risk   4/53 (7.55%)   2/51 (3.92%)   0/51 (0.00%)   0/50 (0.00%) 
Respiratory tract infection viral † 1         
# participants affected / at risk   3/53 (5.66%)   1/51 (1.96%)   0/51 (0.00%)   1/50 (2.00%) 
Tinea pedis † 1         
# participants affected / at risk   2/53 (3.77%)   1/51 (1.96%)   1/51 (1.96%)   1/50 (2.00%) 
Tonsillitis † 1         
# participants affected / at risk   3/53 (5.66%)   1/51 (1.96%)   0/51 (0.00%)   1/50 (2.00%) 
Viral infection † 1         
# participants affected / at risk   1/53 (1.89%)   3/51 (5.88%)   0/51 (0.00%)   1/50 (2.00%) 
Cellulitis † 1         
# participants affected / at risk   0/53 (0.00%)   1/51 (1.96%)   1/51 (1.96%)   2/50 (4.00%) 
Tooth abscess † 1         
# participants affected / at risk   2/53 (3.77%)   1/51 (1.96%)   1/51 (1.96%)   0/50 (0.00%) 
Anogenital warts † 1         
# participants affected / at risk   2/53 (3.77%)   0/51 (0.00%)   1/51 (1.96%)   0/50 (0.00%) 
Furuncle † 1         
# participants affected / at risk   1/53 (1.89%)   0/51 (0.00%)   2/51 (3.92%)   0/50 (0.00%) 
Gonorrhoea † 1         
# participants affected / at risk   0/53 (0.00%)   1/51 (1.96%)   0/51 (0.00%)   2/50 (4.00%) 
Otitis media † 1         
# participants affected / at risk   3/53 (5.66%)   0/51 (0.00%)   0/51 (0.00%)   0/50 (0.00%) 
Tooth infection † 1         
# participants affected / at risk   0/53 (0.00%)   2/51 (3.92%)   1/51 (1.96%)   0/50 (0.00%) 
Urinary tract infection † 1         
# participants affected / at risk   1/53 (1.89%)   0/51 (0.00%)   2/51 (3.92%)   0/50 (0.00%) 
Genital herpes † 1         
# participants affected / at risk   0/53 (0.00%)   0/51 (0.00%)   2/51 (3.92%)   0/50 (0.00%) 
Molluscum contagiosum † 1         
# participants affected / at risk   0/53 (0.00%)   0/51 (0.00%)   2/51 (3.92%)   0/50 (0.00%) 
Injury, poisoning and procedural complications         
Contusion † 1         
# participants affected / at risk   2/53 (3.77%)   0/51 (0.00%)   0/51 (0.00%)   0/50 (0.00%) 
Laceration † 1         
# participants affected / at risk   0/53 (0.00%)   2/51 (3.92%)   0/51 (0.00%)   0/50 (0.00%) 
Investigations         
Blood creatine phosphokinase increased † 1         
# participants affected / at risk   0/53 (0.00%)   3/51 (5.88%)   0/51 (0.00%)   0/50 (0.00%) 
Metabolism and nutrition disorders         
Hyperglycaemia † 1         
# participants affected / at risk   2/53 (3.77%)   0/51 (0.00%)   1/51 (1.96%)   0/50 (0.00%) 
Hypercholesterolaemia † 1         
# participants affected / at risk   0/53 (0.00%)   2/51 (3.92%)   0/51 (0.00%)   0/50 (0.00%) 
Musculoskeletal and connective tissue disorders         
Back pain † 1         
# participants affected / at risk   3/53 (5.66%)   3/51 (5.88%)   2/51 (3.92%)   4/50 (8.00%) 
Arthralgia † 1         
# participants affected / at risk   1/53 (1.89%)   3/51 (5.88%)   2/51 (3.92%)   1/50 (2.00%) 
Musculoskeletal pain † 1         
# participants affected / at risk   1/53 (1.89%)   2/51 (3.92%)   3/51 (5.88%)   0/50 (0.00%) 
Myalgia † 1         
# participants affected / at risk   2/53 (3.77%)   0/51 (0.00%)   2/51 (3.92%)   1/50 (2.00%) 
Muscle spasms † 1         
# participants affected / at risk   0/53 (0.00%)   4/51 (7.84%)   0/51 (0.00%)   0/50 (0.00%) 
Exostosis † 1         
# participants affected / at risk   1/53 (1.89%)   0/51 (0.00%)   2/51 (3.92%)   0/50 (0.00%) 
Pain in extremity † 1         
# participants affected / at risk   0/53 (0.00%)   2/51 (3.92%)   1/51 (1.96%)   0/50 (0.00%) 
Nervous system disorders         
Headache † 1         
# participants affected / at risk   7/53 (13.21%)   6/51 (11.76%)   9/51 (17.65%)   3/50 (6.00%) 
Dizziness † 1         
# participants affected / at risk   2/53 (3.77%)   3/51 (5.88%)   3/51 (5.88%)   11/50 (22.00%) 
Somnolence † 1         
# participants affected / at risk   2/53 (3.77%)   1/51 (1.96%)   1/51 (1.96%)   2/50 (4.00%) 
Paraesthesia † 1         
# participants affected / at risk   2/53 (3.77%)   0/51 (0.00%)   0/51 (0.00%)   2/50 (4.00%) 
Dysgeusia † 1         
# participants affected / at risk   2/53 (3.77%)   1/51 (1.96%)   0/51 (0.00%)   0/50 (0.00%) 
Restless legs syndrome † 1         
# participants affected / at risk   0/53 (0.00%)   0/51 (0.00%)   0/51 (0.00%)   2/50 (4.00%) 
Psychiatric disorders         
Insomnia † 1         
# participants affected / at risk   0/53 (0.00%)   7/51 (13.73%)   6/51 (11.76%)   6/50 (12.00%) 
Depression † 1         
# participants affected / at risk   3/53 (5.66%)   6/51 (11.76%)   2/51 (3.92%)   5/50 (10.00%) 
Anxiety † 1         
# participants affected / at risk   1/53 (1.89%)   2/51 (3.92%)   2/51 (3.92%)   3/50 (6.00%) 
Abnormal dreams † 1         
# participants affected / at risk   1/53 (1.89%)   2/51 (3.92%)   0/51 (0.00%)   4/50 (8.00%) 
Nightmare † 1         
# participants affected / at risk   0/53 (0.00%)   0/51 (0.00%)   0/51 (0.00%)   3/50 (6.00%) 
Stress † 1         
# participants affected / at risk   0/53 (0.00%)   1/51 (1.96%)   2/51 (3.92%)   0/50 (0.00%) 
Renal and urinary disorders         
Nephrolithiasis † 1         
# participants affected / at risk   2/53 (3.77%)   1/51 (1.96%)   1/51 (1.96%)   1/50 (2.00%) 
Proteinuria † 1         
# participants affected / at risk   0/53 (0.00%)   2/51 (3.92%)   1/51 (1.96%)   0/50 (0.00%) 
Reproductive system and breast disorders         
Erectile dysfunction † 1         
# participants affected / at risk   1/53 (1.89%)   0/51 (0.00%)   2/51 (3.92%)   1/50 (2.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough † 1         
# participants affected / at risk   5/53 (9.43%)   4/51 (7.84%)   6/51 (11.76%)   2/50 (4.00%) 
Oropharyngeal pain † 1         
# participants affected / at risk   3/53 (5.66%)   0/51 (0.00%)   3/51 (5.88%)   1/50 (2.00%) 
Sinus congestion † 1         
# participants affected / at risk   0/53 (0.00%)   1/51 (1.96%)   2/51 (3.92%)   2/50 (4.00%) 
Asthma † 1         
# participants affected / at risk   1/53 (1.89%)   2/51 (3.92%)   1/51 (1.96%)   0/50 (0.00%) 
Dyspnoea † 1         
# participants affected / at risk   0/53 (0.00%)   2/51 (3.92%)   1/51 (1.96%)   0/50 (0.00%) 
Respiratory tract congestion † 1         
# participants affected / at risk   0/53 (0.00%)   0/51 (0.00%)   2/51 (3.92%)   0/50 (0.00%) 
Rhinorrhoea † 1         
# participants affected / at risk   0/53 (0.00%)   0/51 (0.00%)   2/51 (3.92%)   0/50 (0.00%) 
Skin and subcutaneous tissue disorders         
Rash † 1         
# participants affected / at risk   5/53 (9.43%)   3/51 (5.88%)   3/51 (5.88%)   6/50 (12.00%) 
Pruritus † 1         
# participants affected / at risk   2/53 (3.77%)   0/51 (0.00%)   1/51 (1.96%)   3/50 (6.00%) 
Dermatitis † 1         
# participants affected / at risk   0/53 (0.00%)   2/51 (3.92%)   1/51 (1.96%)   1/50 (2.00%) 
Night sweats † 1         
# participants affected / at risk   1/53 (1.89%)   1/51 (1.96%)   2/51 (3.92%)   0/50 (0.00%) 
Photosensitivity reaction † 1         
# participants affected / at risk   0/53 (0.00%)   0/51 (0.00%)   2/51 (3.92%)   1/50 (2.00%) 
Vascular disorders         
Hypertension † 1         
# participants affected / at risk   0/53 (0.00%)   1/51 (1.96%)   0/51 (0.00%)   2/50 (4.00%) 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA



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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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