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Trial record 19 of 42 for:    " September 14, 2011":" October 14, 2011"[FIRST-RECEIVED-DATE]AND HIV[CONDITION]

Dolutegravir Compared to Darunavir/Ritonavir , Each in Combination With Dual Nucleoside Reverse Transcriptase Inhibitors (NRTIs) in ART-naive Subjects (FLAMINGO)

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ClinicalTrials.gov Identifier: NCT01449929
Recruitment Status : Completed
First Posted : October 10, 2011
Results First Posted : March 27, 2014
Last Update Posted : January 16, 2018
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
ViiV Healthcare

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Infection, Human Immunodeficiency Virus
Interventions Drug: dolutegravir 50 mg OAD
Drug: darunavir 800mg OAD
Drug: ritonavir 100mg OAD
Enrollment 488
Recruitment Details This was a 2 sequential treatment period study. In first period (Randomization phase) participants received either dolutegravir (DTG) 50 milligram (mg) or darunavir (DRV) 800 mg with ritonavir (RTV) 100 mg once daily (QD) for 96 weeks. DTG participants who completed 96 Weeks of DTG then continued to receive DTG 50 mg in Extension phase.
Pre-assignment Details A total of 595 participants were screened; 107 were screen failures; 488 were randomized; 485 received at least 1 dose of study medication and comprised the Intent-To-Treat exposed (ITT-E) population of which 1 participant was removed, creating the modified ITT-E population with 484 participants. 123 participants enrolled in Extension Phase.
Arm/Group Title DTG 50 mg QD DRV 800 mg + RTV 100 mg QD Extension DTG 50 mg
Hide Arm/Group Description Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study. Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. DTG participants who successfully completed 96 Weeks of randomized phase continued to receive DTG 50 mg QD during Extension phase
Period Title: Randomization Phase 96 Week
Started 242 242 0
Completed 209 189 0
Not Completed 33 53 0
Reason Not Completed
Adverse Event             5             13             0
Lack of Efficacy             3             4             0
Protocol Violation             5             6             0
Protocol-defined Stopping Criteria             1             0             0
Lost to Follow-up             15             18             0
Withdrawal by Subject             2             8             0
Physician Decision             2             3             0
Other: study closed/terminated             0             1             0
Period Title: Extension Phase Approximately 3 Years
Started 0 0 123
Completed 0 0 115
Not Completed 0 0 8
Reason Not Completed
Adverse Event             0             0             2
Lack of Efficacy             0             0             2
Lost to Follow-up             0             0             4
Arm/Group Title DTG 50 mg QD DRV 800 mg + RTV 100 mg QD Total
Hide Arm/Group Description Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study. Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Total of all reporting groups
Overall Number of Baseline Participants 242 242 484
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 242 participants 242 participants 484 participants
35.7  (10.66) 36.2  (10.64) 35.9  (10.64)
[1]
Measure Description: Results from the mITT-E Population are presented in this report.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 242 participants 242 participants 484 participants
Female
31
  12.8%
41
  16.9%
72
  14.9%
Male
211
  87.2%
201
  83.1%
412
  85.1%
[1]
Measure Description: Results from the mITT-E are presented in this report.
Race/Ethnicity, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 242 participants 242 participants 484 participants
African American/African Heritage 60 53 113
American Indian or Alaska Native 3 9 12
Asian - Central/South Asian Heritage 0 1 1
Asian - Japanese Heritage 1 0 1
Asian - South East Asian Heritage 1 0 1
Native Hawaiian or other Pacific Islander 2 0 2
White - Arabic/North African Heritage 4 3 7
White - White/Caucasian/European Heritage 169 173 342
Mixed Race 1 3 4
Missing 1 0 1
[1]
Measure Description: Results from the mITT-E are presented in this report.
1.Primary Outcome
Title Percentage of Participants With Plasma Human Immunodeficiency Virus-1 (HIV-1) Ribonucleic Acid (RNA) <50 Copies/Milliliter (c/mL) at Week 48
Hide Description Assessment was done using Missing, Switch or Discontinuation = Failure (MSDF), as codified by the Food and Drug Administration (FDA) "snapshot" algorithm.This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks). Modified Intent-To-Treat Exposed (mITT-E) Population:all randomized participants who received at least one dose of investigational product
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT-E Population
Arm/Group Title DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
Hide Arm/Group Description:
Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Overall Number of Participants Analyzed 242 242
Measure Type: Number
Unit of Measure: Percentage of participants
90 83
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection DTG 50 mg QD, DRV 800 mg + RTV 100 mg QD
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments Non-inferiority of DTG 50 mg and DRV+RTV at Week 48 can be concluded if the lower bound of a two-sided 95% confidence interval (CI) for the difference in percentages (DTG - DRV+RTV) is greater than -12%. If non-inferiority is established, superiority can be tested at the nominal 5% level based on a pre-specified testing procedure.
Statistical Test of Hypothesis P-Value 0.025
Comments P-value is for test of superiority.
Method Cochran-Mantel-Haenszel
Comments Stratified analysis
Method of Estimation Estimation Parameter Difference in percentage
Estimated Value 7.1
Confidence Interval (2-Sided) 95%
0.9 to 13.2
Estimation Comments Analysis was adjusted for the Baseline (BL) stratification factors: Baseline plasma HIV-1 RNA (<=100,000 c/mL vs >100,000 c/mL) and Baseline background dual NRTI therapy (ABC/3TC vs TDF/FTC).
2.Secondary Outcome
Title Time to Virologic Suppression (<50 Copies/mL) Through Week 48
Hide Description The time to viral suppression (i.e. first viral load value <50 copies/mL) through Week 48 was derived and summarized using Kaplan-Meier plots. Participants who withdrew for any reason without having suppressed prior to the analysis were censored. Confidence intervals were estimated using the Brookmeyer-Crowley method.
Time Frame From Baseline through Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT-E Population
Arm/Group Title DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
Hide Arm/Group Description:
Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Overall Number of Participants Analyzed 242 242
Median (95% Confidence Interval)
Unit of Measure: Days
28.0 [1] 
(NA to NA)
85.0
(84.0 to 108.0)
[1]
The DTG median time to suppression 95% CI was not estimable due to the steep increase in cumulative incidence at Day 28, so the confidence limit lines do not extend to cross the median line.
3.Secondary Outcome
Title Percentage of Participants With Plasma HIV-1 RNA <400 c/mL at Week 48
Hide Description The percentage of participants with Plasma HIV-1 RNA <400 c/mL at Week 48 was assessed MSDF, as codified by the FDA "snapshot" algorithm. This algorithm treated all participants without HIV-1 RNA data at Week 48 as nonresponders, as well as participants who switched their concomitant ART prior to Week 48 as follows: background ART substitutions non-permitted per protocol (one background ART substitution was permitted for safety or tolerability); background ART substitutions permitted per protocol unless the decision to switch was documented as being before or at the first on-treatment visit where HIV-1 RNA was assessed. Otherwise, virologic success or failure was determined by the last available HIV-1 RNA assessment while the participant was on-treatment in the snapshot window (Week 48 +/- 6 weeks).
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT-E Population
Arm/Group Title DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
Hide Arm/Group Description:
Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Overall Number of Participants Analyzed 242 242
Measure Type: Number
Unit of Measure: Percentage of participants
92 87
4.Secondary Outcome
Title Change From Baseline in Plasma HIV-1 RNA (log10 c/mL) at Weeks 4, 8, 12, 16, 24, 36 and 48
Hide Description Change from Baseline in plasma HIV-1 RNA (log10 c/mL) was assessed at Weeks 4, 8, 12, 16, 24, 36 and 48 . Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the mITT-E Population.
Time Frame Baseline, Weeks 4, 8, 12, 16, 24, 36 and 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT-E Population.
Arm/Group Title DTG 50 mg OD DRV 800 mg + RTV 100 mg OD
Hide Arm/Group Description:
Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg OD during an Extension Phase of the study.
Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Overall Number of Participants Analyzed 242 242
Mean (Standard Deviation)
Unit of Measure: Log10 copies per mL
Week 4, n=238, 235 Number Analyzed 238 participants 235 participants
-2.80  (0.625) -2.01  (0.454)
Week 8, n=237, 236 Number Analyzed 237 participants 236 participants
-2.86  (0.649) -2.40  (0.524)
Week 12, n=234, 227 Number Analyzed 234 participants 227 participants
-2.88  (0.653) -2.61  (0.537)
Week 16, n=229, 228 Number Analyzed 229 participants 228 participants
-2.86  (0.691) -2.71  (0.618)
Week 24, n=234, 227 Number Analyzed 234 participants 227 participants
-2.86  (0.765) -2.83  (0.663)
Week 36, n=232, 218 Number Analyzed 232 participants 218 participants
-2.87  (0.715) -2.85  (0.683)
Week 48, n=227, 212 Number Analyzed 227 participants 212 participants
-2.89  (0.739) -2.86  (0.663)
5.Secondary Outcome
Title Change From Baseline in CD4+ and CD8+ Cell Counts
Hide Description Change from Baseline in CD4+ cell counts was assessed at Weeks 4, 8, 12, 16, 36 and 48. Change from Baseline in CD8+ cell counts was assessed at Weeks 4, 12, 24 and 48. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits and parameters, so the overall number of participants analyzed reflects everyone in the mITT-E Population.
Time Frame Baseline and Weeks 4, 8, 12, 16, 36 and 48 for CD4+ and Baseline and Weeks 4, 12, 24 and 48 for CD8+
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT-E Population.
Arm/Group Title DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
Hide Arm/Group Description:
Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Overall Number of Participants Analyzed 242 242
Mean (Standard Deviation)
Unit of Measure: Cells per millimeters cubed (cells/mm^3)
CD4+ cell count, Week 4, n=237, 236 Number Analyzed 237 participants 236 participants
80.1  (101.36) 75.6  (124.36)
CD4+ cell count, Week 8, n=236, 236 Number Analyzed 236 participants 236 participants
126.9  (124.13) 118.8  (142.54)
CD4+ cell count, Week 12, n=234, 228 Number Analyzed 234 participants 228 participants
135.2  (120.03) 131.8  (143.88)
CD4+ cell count, Week 16, n=227, 227 Number Analyzed 227 participants 227 participants
156.8  (146.60) 146.1  (166.08)
CD4+ cell count, Week 24, n=233, 227 Number Analyzed 233 participants 227 participants
165.1  (145.85) 164.3  (180.00)
CD4+ cell count, Week 36, n=232, 218 Number Analyzed 232 participants 218 participants
206.1  (159.06) 186.5  (183.61)
CD4+ cell count, Week 48, n=227, 212 Number Analyzed 227 participants 212 participants
243.8  (180.68) 215.4  (177.26)
CD8+ cell count, Week 4, n=235, 235 Number Analyzed 235 participants 235 participants
-47.4  (276.01) -3.7  (375.94)
CD8+ cell count, Week 12, n=231, 227 Number Analyzed 231 participants 227 participants
-42.0  (343.81) -68.9  (373.38)
CD8+ cell count, Week 24, n=231, 224 Number Analyzed 231 participants 224 participants
-108.0  (350.03) -132.9  (389.70)
CD8+ cell count, Week 48, n=224, 210 Number Analyzed 224 participants 210 participants
-109.5  (360.94) -162.1  (421.07)
6.Secondary Outcome
Title Number of Participants With HIV-1 Associated Disease Progression With the Indicated Shift to CDC Class C, or New CDC Class C or Death at Week 48
Hide Description The number of participants with HIV-1 disease progression (AIDS or death) was assessed per the Centers for Disease Control and Prevention (CDC) 1993 revised classification system for HIV infection and expanded surveillance case definition for AIDS among adolescents and adults. The CDC classifies HIV infection as Category A (participants with asymptomatic HIV infection, acute HIV infection with accompanying illness, or persistent generalized lymphadenopathy), Category B (participants with symptomatic non-AIDS condition, i.e., conditions that are attributed to HIV infection or are indicative of a defect in cell-mediated immunity; or conditions are considered by physicians to have a clinical course or to require management that is complicated by HIV infection), and Category C (includes AIDS indicator conditions as defined by diagnostic or presumptive measures).
Time Frame Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT-E Population
Arm/Group Title DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
Hide Arm/Group Description:
Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Overall Number of Participants Analyzed 242 242
Measure Type: Number
Unit of Measure: Participants
0 0
7.Secondary Outcome
Title Change From Baseline in Fasting Low-density Lipoprotein (LDL) Cholesterol Through Week 48
Hide Description Fasting LDL cholesterol change from Baseline was analyzed. Values represented are for adjusted means. Estimates are calculated from a repeated measures model including the following covariates: treatment, visit, Baseline plasma HIV-1 RNA, background dual NRTI therapy, Baseline LDL cholesterol, treatment*visit interaction and Baseline LDL cholesterol*visit interaction. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants with data available at the specified time points were analyzed.
Time Frame From Baseline through Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mSafety Population.
Arm/Group Title DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
Hide Arm/Group Description:
Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Overall Number of Participants Analyzed 182 178
Mean (Standard Error)
Unit of Measure: Millimoles per liter (mmol/L)
0.07  (0.041) 0.37  (0.041)
8.Secondary Outcome
Title Percentage of Participants With Grade 2 or Higher Abnormalities in Fasting LDL Cholesterol Through Week 48
Hide Description Hematology and clinical chemistry data were summarized according to the division of AIDS (DAIDS) table for grading the Severity of adverse events, version 1.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for which an increase in fasting LDL cholesterol to Grade 2 or higher occurred. Only those participants with data available at the specified time points were analyzed.
Time Frame From Baseline through Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mSafety Population.
Arm/Group Title DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
Hide Arm/Group Description:
Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Overall Number of Participants Analyzed 242 242
Measure Type: Number
Unit of Measure: Percentage of Participants
2 7
9.Secondary Outcome
Title Number of Participants With the Indicated Grade 3 and Grade 4 Maximum Post-Baseline Chemistry and Hematology Laboratory Toxicities
Hide Description Hematology and clinical chemistry data were summarized according to the division of AIDS (DAIDS) table for grading the Severity of adverse events, version 1.0. Grade 1, Mild; Grade 2, Moderate; Grade 3 (G3), Severe; Grade 4 (G4), Life-threatening or disabling; Grade 5, Death. Data are presented for only those parameters for which an increase to Grade 3 or Grade 4 occurred.
Time Frame From Baseline through Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mSafety Population
Arm/Group Title DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
Hide Arm/Group Description:
Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Overall Number of Participants Analyzed 242 242
Measure Type: Number
Unit of Measure: Participants
Alanine Amino Transferase, G3 2 1
Alanine Amino Transferase, G4 1 3
Aspartate Amino Transferase, G3 6 3
Aspartate Amino Transferase, G4 2 0
Cholesterol, G3 0 3
Creatine Kinase, G3 8 5
Creatine Kinase, G4 8 4
Hyperglycaemia, G3 1 2
Hypoglycaemia, G3 0 1
LDL Cholesterol, G3 2 6
Lipase, G3 5 5
Lipase, G4 2 0
Phosphorus, inorganic, G3 7 7
Total Bilirubin, G3 1 0
Triglycerides, G3 1 2
Triglycerides, G4 0 1
Hemoglobin, G3 1 0
Hemoglobin, G4 1 0
Platelet count, G4 0 1
Total Neutrophils, G3 5 0
Total Neutrophils, G4 3 1
10.Secondary Outcome
Title Number of Participants (Par.) With Detectable Virus That Has Genotypic or Phenotypic Evidence of Treatment-emergent Resistance to DTG, DRV+RTV and Other On-study ART at Time of Protocol Defined Virology Failure (PDVF)
Hide Description An assessment was made of every change across all amino acids within the integrase (IN), reverse transcriptase (RT), and Protease (PRO) encoding region at Baseline and at time of suspected PDVF. PDVF is defined as the confirmed plasma HIV-1 RNA >200 c/mL >=Week 24. PDVF Genotypic Population included all participants in the mITT-E population with available on-treatment genotypic resistance data, at time of PDVF. Only those participants with data available at the specified time points were analyzed.
Time Frame Baseline until PDVF up to Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
PDVF Genotypic Population
Arm/Group Title DTG 50 mg OD DRV 800 mg + RTV 100 mg OD
Hide Arm/Group Description:
Participants received DTG 50 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg OD during an Extension Phase of the study.
Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Overall Number of Participants Analyzed 2 2
Measure Type: Number
Unit of Measure: Participants
0 0
11.Secondary Outcome
Title Change From Baseline in Acquired Immune Deficiency Syndrome (AIDS) Clinical Trials Group (ACTG) Symptom Distress Module (SDM) Bother Score at Week 4, Week 24, and Week 48
Hide Description SDM is a 20-item self-reported measure that addresses the presence and perceived distress linked to symptoms commonly associated with HIV or its treatment. Each item is rated from 0 to 4 where 0 (complete absence of symptom) and 4 (very bothersome symptom). Overall score calculated as the sum of the scores for each of the 20 items of the questionnaire and ranged from 0 (best health) and 80 (worst health). Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, baseline viral load, background dual NRTI therapy and baseline symptom bother score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. A positive change from Baseline indicates a decline in a participant’s quality of life over that period.
Time Frame Baseline, Week 4, Week 24, and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the mITT-E Population.
Arm/Group Title DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
Hide Arm/Group Description:
Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
Participants received DRV 800 mg + RTV 100 mg OD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Overall Number of Participants Analyzed 242 242
Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 4, n=218, 210 Number Analyzed 218 participants 210 participants
-3.20  (0.56) -2.19  (0.56)
Week 24, n=222, 214 Number Analyzed 222 participants 214 participants
-2.71  (0.64) -1.65  (0.65)
Week 48, n= 222, 215 Number Analyzed 222 participants 215 participants
-2.46  (0.68) -0.77  (0.69)
12.Secondary Outcome
Title Change From Baseline in European Quality of Life -5 Dimensions (EQ-5D) Utility Scores at Week 24 and Week 48
Hide Description The EQ-5D is a 5-question quality of life instrument that provides a utility score and visual analogue scale score that describes the participants’ health status. The primary reason for including the EQ-5D is to elicit utility values for potential cost-effectiveness analysis for submission to health technology assessment agencies. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome. Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, baseline viral load, background dual NRTI therapy and Baseline EQ-5D utility score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 24, and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT-E Population.
Arm/Group Title DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
Hide Arm/Group Description:
Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Overall Number of Participants Analyzed 242 242
Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 24, n=217, 213 Number Analyzed 217 participants 213 participants
0.00  (0.012) 0.02  (0.012)
Week 48, n=224, 217 Number Analyzed 224 participants 217 participants
0.01  (0.012) 0.01  (0.012)
13.Secondary Outcome
Title Change From Baseline in EQ-5D Thermometer Scores at Week 24 and Week 48
Hide Description The European Quality of Life -5 Dimensions (EQ-5D) is a 5-question quality of life instrument that provides a utility score and visual analogue scale score that describes the participants’ health status. The primary reason for including the EQ-5D is to elicit utility values for potential cost-effectiveness analysis for submission to health technology assessment agencies. Thermometer score is based on a visual analogue scale (VAS) ranging from 100 (best imaginable health state) to 0 (worst imaginable health state).Values represented are for adjusted mean. Estimates are calculated from an ANCOVA model adjusting for age, sex, race, Baseline viral load, background dual NRTI therapy and Baseline EQ-5D thermometer score. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles).
Time Frame Baseline, Week 24, and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
mITT-E Population.
Arm/Group Title DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
Hide Arm/Group Description:
Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Overall Number of Participants Analyzed 242 242
Mean (Standard Error)
Unit of Measure: Scores on a scale
Week 24, n=221, 216 Number Analyzed 221 participants 216 participants
4.95  (0.885) 5.96  (0.895)
Week 48, n=224, 220 Number Analyzed 224 participants 220 participants
5.78  (0.762) 6.95  (0.769)
14.Secondary Outcome
Title Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Total Score at Week 4, Week 24, and Week 48
Hide Description Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The treatment satisfaction score (range: 0-60) was the sum of the individual items. HIVTSQ mITT-E Population=Only participants from USA, France, Germany, Italy, Spain for whom valid translations were available from the mITT-E Population. Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.
Time Frame Week 4, Week 24, and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
HIVTSQ mITT-E Population.
Arm/Group Title DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
Hide Arm/Group Description:
Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Overall Number of Participants Analyzed 214 206
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 4, n=206, 192 Number Analyzed 206 participants 192 participants
54.1  (6.43) 52.4  (7.94)
Week 24, n= 211, 200 Number Analyzed 211 participants 200 participants
56.1  (5.16) 54.3  (6.94)
Week 48, n=212, 201 Number Analyzed 212 participants 201 participants
56.1  (4.60) 54.5  (6.78)
15.Secondary Outcome
Title Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Lifestyle/Ease Sub Score at Week 4, Week 24, and Week 48
Hide Description Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The lifestyle/ease score is the sum of items 4, 5, 6, 7 and 8 (range: 0-30). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.
Time Frame Week 4, Week 24, and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
HIVTSQ mITT-E Population.
Arm/Group Title DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
Hide Arm/Group Description:
Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Overall Number of Participants Analyzed 214 206
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 4, n=202, 190 Number Analyzed 202 participants 190 participants
26.7  (3.61) 25.8  (4.48)
Week 24, n=210, 199 Number Analyzed 210 participants 199 participants
27.5  (3.16) 26.6  (4.11)
Week 48, n=211, 201 Number Analyzed 211 participants 201 participants
27.6  (3.00) 26.6  (4.11)
16.Secondary Outcome
Title Human Immunodeficiency Virus Treatment Satisfaction Questionnaire (HIVTSQ) Convenience Score at Week 4, Week 24, and Week 48
Hide Description Participant treatment satisfaction was measured using the self-reported scale (HIVTSQ), which consists of 10 items (1-satisfaction, 2-HIV control, 3-adverse effects, 4-level of demand, 5-convenience, 6-flexibility, 7-knowledge, 8-life habits, 9-recommendability, and 10-willingness to continue). Items are scored from 0 (very dissatisfied) to 6 (very satisfied), other than item 4, which has an inverted score from 6 (very demanding) to 0 (very undemanding). The convenience score is the score for item 5 (range: 0-6). Only those participants available at the specified time points were analyzed (represented by n=X, X in the category titles). Different participants may have been analyzed for different visits, so the overall number of participants analyzed reflects everyone in the HIVTSQ mITT-E population.
Time Frame Week 4, Week 24, and Week 48
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
HIVTSQ mITT-E Population.
Arm/Group Title DTG 50 mg QD DRV 800 mg + RTV 100 mg QD
Hide Arm/Group Description:
Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study.
Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks.
Overall Number of Participants Analyzed 214 206
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Week 4, n=204, 190 Number Analyzed 204 participants 190 participants
5.6  (0.71) 5.2  (1.11)
Week 24, n=211, 200, Number Analyzed 211 participants 200 participants
5.6  (0.64) 5.4  (1.01)
Week 48, n=212, 201 Number Analyzed 212 participants 201 participants
5.7  (0.62) 5.4  (1.02)
Time Frame Serious adverse events (SAEs) and non-serious adverse events (AEs) are presented from the available safety data from the start of the study medication up to end of study.
Adverse Event Reporting Description SAEs and non-serious AEs were reported for members of the Modified Safety Population, comprised of all participants who received at least one dose of investigational product excluding one participant at one site, which was closed due to GCP non-compliance issues in another ViiV Healthcare sponsored trial.
 
Arm/Group Title DTG 50mg QD DRV 800 mg + RTV 100 mg QD Extension DTG 50 mg
Hide Arm/Group Description Participants received DTG 50 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. Participants were then given the opportunity to receive DTG 50 mg QD during an Extension Phase of the study. Participants received DRV 800 mg + RTV 100 mg QD administered in combination with FDC dual NRTI therapy (either ABC/3TC or TDF/FTC) for 96 weeks. DTG participants who successfully completed 96 Weeks of randomized phase continued to receive DTG 50 mg QD during Extension phase
All-Cause Mortality
DTG 50mg QD DRV 800 mg + RTV 100 mg QD Extension DTG 50 mg
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/242 (0.41%)      0/242 (0.00%)      0/123 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
DTG 50mg QD DRV 800 mg + RTV 100 mg QD Extension DTG 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   36/242 (14.88%)      21/242 (8.68%)      4/123 (3.25%)    
Blood and lymphatic system disorders       
Methaemoglobinaemia  1  0/242 (0.00%)  0 0/242 (0.00%)  0 1/123 (0.81%)  1
Cardiac disorders       
Cardiomyopathy alcoholic  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Congestive cardiomyopathy  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Coronary artery disease  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Myocardial infarction  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Myocarditis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Gastrointestinal disorders       
Abdominal adhesions  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Anal fistula  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Constipation  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Diarrhoea haemorrhagic  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Haematemesis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Haemorrhoids  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Odynophagia  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Pancreatitis acute  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Small intestinal obstruction  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Hepatobiliary disorders       
Cholelithiasis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Immune system disorders       
Allergy to arthropod sting  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Drug hypersensitivity  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Infections and infestations       
Acute hepatitis C  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Acute sinusitis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Appendicitis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Bronchitis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Gastroenteritis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Herpes zoster disseminated  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Herpes zoster infection neurological  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Neurosyphilis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Perineal abscess  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Pneumonia  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Pneumonia bacterial  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Proctitis infectious  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Pulmonary tuberculosis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Pyelonephritis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Sepsis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Staphylococcal infection  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Subcutaneous abscess  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Tonsillitis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Urinary tract infection  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Injury, poisoning and procedural complications       
Accidental overdose  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Back injury  1  0/242 (0.00%)  0 0/242 (0.00%)  0 1/123 (0.81%)  1
Postoperative ileus  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Stab wound  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Tendon rupture  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Tibia fracture  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Toxicity to various agents  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Intervertebral disc protrusion  1  0/242 (0.00%)  0 0/242 (0.00%)  0 1/123 (0.81%)  1
Myofascial pain syndrome  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Polyarthritis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Hodgkin's disease  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Nervous system disorders       
Cerebrovascular accident  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Epilepsy  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Generalised tonic-clonic seizure  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Lacunar stroke  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Syncope  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Pregnancy, puerperium and perinatal conditions       
Abortion spontaneous  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Complication of pregnancy  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Psychiatric disorders       
Suicide attempt  1  3/242 (1.24%)  3 0/242 (0.00%)  0 1/123 (0.81%)  1
Depression  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Completed suicide  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Drug use disorder  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Renal and urinary disorders       
Acute kidney injury  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Calculus urinary  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Asthma  1  2/242 (0.83%)  3 0/242 (0.00%)  0 0/123 (0.00%)  0
Chronic obstructive pulmonary disease  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
DTG 50mg QD DRV 800 mg + RTV 100 mg QD Extension DTG 50 mg
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   221/242 (91.32%)      214/242 (88.43%)      52/123 (42.28%)    
Blood and lymphatic system disorders       
Lymphadenopathy  1  7/242 (2.89%)  7 6/242 (2.48%)  6 0/123 (0.00%)  0
Neutropenia  1  3/242 (1.24%)  3 3/242 (1.24%)  3 0/123 (0.00%)  0
Anaemia  1  3/242 (1.24%)  3 1/242 (0.41%)  1 0/123 (0.00%)  0
Eosinophilia  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Haemorrhagic anaemia  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Leukocytosis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Leukopenia  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Cardiac disorders       
Palpitations  1  4/242 (1.65%)  4 0/242 (0.00%)  0 0/123 (0.00%)  0
Extrasystoles  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Tachycardia  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Arrhythmia  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Atrioventricular block second degree  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Bradycardia  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Bundle branch block left  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Cardiac failure  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Cardiac failure congestive  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Myocardial infarction  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Pericarditis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Ventricular hypertrophy  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Congenital, familial and genetic disorders       
Bicuspid aortic valve  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Type V hyperlipidaemia  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Ear and labyrinth disorders       
Ear congestion  1  2/242 (0.83%)  3 1/242 (0.41%)  1 0/123 (0.00%)  0
Tinnitus  1  1/242 (0.41%)  3 1/242 (0.41%)  1 1/123 (0.81%)  1
Vertigo  1  0/242 (0.00%)  0 3/242 (1.24%)  4 0/123 (0.00%)  0
Deafness  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Cerumen impaction  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Ear canal erythema  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Tympanic membrane perforation  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Endocrine disorders       
Hypogonadism  1  2/242 (0.83%)  2 2/242 (0.83%)  2 0/123 (0.00%)  0
Eye disorders       
Vision blurred  1  2/242 (0.83%)  2 1/242 (0.41%)  1 0/123 (0.00%)  0
Chalazion  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Vitreous floaters  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Cataract  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Keratitis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Scleral discolouration  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Xerophthalmia  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Gastrointestinal disorders       
Diarrhoea  1  43/242 (17.77%)  46 74/242 (30.58%)  98 2/123 (1.63%)  2
Nausea  1  40/242 (16.53%)  45 48/242 (19.83%)  56 2/123 (1.63%)  2
Vomiting  1  15/242 (6.20%)  16 17/242 (7.02%)  22 0/123 (0.00%)  0
Abdominal pain  1  13/242 (5.37%)  14 12/242 (4.96%)  12 0/123 (0.00%)  0
Constipation  1  13/242 (5.37%)  13 5/242 (2.07%)  5 0/123 (0.00%)  0
Abdominal distension  1  8/242 (3.31%)  10 9/242 (3.72%)  9 0/123 (0.00%)  0
Flatulence  1  5/242 (2.07%)  6 11/242 (4.55%)  11 0/123 (0.00%)  0
Haemorrhoids  1  8/242 (3.31%)  8 6/242 (2.48%)  6 1/123 (0.81%)  1
Abdominal pain upper  1  10/242 (4.13%)  10 4/242 (1.65%)  4 0/123 (0.00%)  0
Dyspepsia  1  5/242 (2.07%)  6 7/242 (2.89%)  9 0/123 (0.00%)  0
Gastrooesophageal reflux disease  1  6/242 (2.48%)  8 4/242 (1.65%)  4 0/123 (0.00%)  0
Abdominal discomfort  1  3/242 (1.24%)  3 6/242 (2.48%)  7 0/123 (0.00%)  0
Rectal haemorrhage  1  4/242 (1.65%)  4 3/242 (1.24%)  3 1/123 (0.81%)  1
Faeces soft  1  3/242 (1.24%)  3 3/242 (1.24%)  3 0/123 (0.00%)  0
Anal fissure  1  2/242 (0.83%)  2 3/242 (1.24%)  3 0/123 (0.00%)  0
Dry mouth  1  3/242 (1.24%)  4 2/242 (0.83%)  2 0/123 (0.00%)  0
Toothache  1  2/242 (0.83%)  2 3/242 (1.24%)  3 0/123 (0.00%)  0
Dental caries  1  2/242 (0.83%)  2 2/242 (0.83%)  2 0/123 (0.00%)  0
Gastritis  1  1/242 (0.41%)  1 3/242 (1.24%)  3 0/123 (0.00%)  0
Proctalgia  1  4/242 (1.65%)  4 0/242 (0.00%)  0 0/123 (0.00%)  0
Aphthous ulcer  1  3/242 (1.24%)  3 0/242 (0.00%)  0 0/123 (0.00%)  0
Colitis  1  2/242 (0.83%)  2 1/242 (0.41%)  1 0/123 (0.00%)  0
Haematochezia  1  2/242 (0.83%)  2 1/242 (0.41%)  1 0/123 (0.00%)  0
Proctitis  1  2/242 (0.83%)  2 1/242 (0.41%)  1 0/123 (0.00%)  0
Anal ulcer  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Anogenital dysplasia  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Anorectal disorder  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Diarrhoea haemorrhagic  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Enterocolitis  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Food poisoning  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Frequent bowel movements  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Haemorrhoidal haemorrhage  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Oral pain  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Tongue coated  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Abdominal hernia  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Abdominal pain lower  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Abdominal tenderness  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Anal haemorrhage  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Anal pruritus  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Anorectal discomfort  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Colitis microscopic  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Crohn's disease  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Dysphagia  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Epigastric discomfort  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Gastrointestinal disorder  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Gastrointestinal erosion  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Gastrointestinal inflammation  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Gingival disorder  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Gingival recession  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Glossodynia  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Haemorrhoids thrombosed  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Hyperchlorhydria  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Inguinal hernia  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Intestinal polyp  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Leukoplakia oral  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Mouth ulceration  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Mucous stools  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Noninfective gingivitis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Odynophagia  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Oedema mouth  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Oesophagitis  1  0/242 (0.00%)  0 0/242 (0.00%)  0 1/123 (0.81%)  1
Palatal disorder  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Pancreatitis chronic  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Rectal lesion  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Stomatitis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Tongue disorder  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Tongue dry  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Tongue ulceration  1  0/242 (0.00%)  0 0/242 (0.00%)  0 1/123 (0.81%)  1
Tooth impacted  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
General disorders       
Pyrexia  1  16/242 (6.61%)  17 16/242 (6.61%)  17 0/123 (0.00%)  0
Fatigue  1  15/242 (6.20%)  17 14/242 (5.79%)  15 0/123 (0.00%)  0
Asthenia  1  5/242 (2.07%)  7 11/242 (4.55%)  11 2/123 (1.63%)  2
Influenza like illness  1  9/242 (3.72%)  11 6/242 (2.48%)  7 0/123 (0.00%)  0
Chest pain  1  3/242 (1.24%)  3 7/242 (2.89%)  8 0/123 (0.00%)  0
Pain  1  3/242 (1.24%)  3 5/242 (2.07%)  6 0/123 (0.00%)  0
Chills  1  2/242 (0.83%)  2 4/242 (1.65%)  4 0/123 (0.00%)  0
Feeling hot  1  2/242 (0.83%)  2 4/242 (1.65%)  5 0/123 (0.00%)  0
Malaise  1  3/242 (1.24%)  3 2/242 (0.83%)  2 0/123 (0.00%)  0
Peripheral swelling  1  3/242 (1.24%)  3 2/242 (0.83%)  2 0/123 (0.00%)  0
Local swelling  1  1/242 (0.41%)  1 2/242 (0.83%)  2 0/123 (0.00%)  0
Chest discomfort  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Discomfort  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Thirst  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Abscess sterile  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Axillary pain  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Cyst  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Dysplasia  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Feeling abnormal  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Hunger  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Nodule  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Oedema peripheral  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Submandibular mass  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Systemic inflammatory response syndrome  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Thirst decreased  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Vaccination site erythema  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Hepatobiliary disorders       
Cholelithiasis  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Hepatic steatosis  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Gallbladder cholesterolosis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Hepatitis alcoholic  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Hepatosplenomegaly  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Immune system disorders       
Seasonal allergy  1  3/242 (1.24%)  3 3/242 (1.24%)  3 1/123 (0.81%)  1
Hypersensitivity  1  4/242 (1.65%)  5 1/242 (0.41%)  1 1/123 (0.81%)  1
Multiple allergies  1  1/242 (0.41%)  1 3/242 (1.24%)  3 0/123 (0.00%)  0
Drug hypersensitivity  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Food allergy  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Jarisch-Herxheimer reaction  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Infections and infestations       
Viral upper respiratory tract infection  1  26/242 (10.74%)  33 24/242 (9.92%)  26 5/123 (4.07%)  5
Upper respiratory tract infection  1  16/242 (6.61%)  22 27/242 (11.16%)  30 1/123 (0.81%)  1
Bronchitis  1  12/242 (4.96%)  12 17/242 (7.02%)  20 0/123 (0.00%)  0
Gastroenteritis  1  12/242 (4.96%)  13 14/242 (5.79%)  16 3/123 (2.44%)  3
Pharyngitis  1  11/242 (4.55%)  11 14/242 (5.79%)  15 1/123 (0.81%)  1
Syphilis  1  11/242 (4.55%)  12 12/242 (4.96%)  12 2/123 (1.63%)  2
Sinusitis  1  9/242 (3.72%)  10 13/242 (5.37%)  14 0/123 (0.00%)  0
Influenza  1  4/242 (1.65%)  4 11/242 (4.55%)  11 2/123 (1.63%)  2
Folliculitis  1  7/242 (2.89%)  7 6/242 (2.48%)  6 0/123 (0.00%)  0
Urethritis  1  8/242 (3.31%)  8 4/242 (1.65%)  4 1/123 (0.81%)  1
Conjunctivitis  1  4/242 (1.65%)  4 7/242 (2.89%)  7 1/123 (0.81%)  1
Gonorrhoea  1  8/242 (3.31%)  9 4/242 (1.65%)  4 0/123 (0.00%)  0
Rhinitis  1  4/242 (1.65%)  4 6/242 (2.48%)  8 1/123 (0.81%)  1
Urinary tract infection  1  7/242 (2.89%)  7 4/242 (1.65%)  5 0/123 (0.00%)  0
Tonsillitis  1  5/242 (2.07%)  5 3/242 (1.24%)  4 1/123 (0.81%)  1
Oral herpes  1  6/242 (2.48%)  6 2/242 (0.83%)  2 0/123 (0.00%)  0
Respiratory tract infection  1  2/242 (0.83%)  3 5/242 (2.07%)  5 1/123 (0.81%)  1
Furuncle  1  3/242 (1.24%)  3 4/242 (1.65%)  5 0/123 (0.00%)  0
Herpes zoster  1  2/242 (0.83%)  2 5/242 (2.07%)  5 0/123 (0.00%)  0
Nasopharyngitis  1  3/242 (1.24%)  3 2/242 (0.83%)  2 2/123 (1.63%)  2
Tooth abscess  1  1/242 (0.41%)  1 5/242 (2.07%)  7 1/123 (0.81%)  1
Viral infection  1  6/242 (2.48%)  6 1/242 (0.41%)  1 0/123 (0.00%)  0
Acarodermatitis  1  5/242 (2.07%)  5 1/242 (0.41%)  1 0/123 (0.00%)  0
Chlamydial infection  1  2/242 (0.83%)  2 3/242 (1.24%)  3 1/123 (0.81%)  1
Fungal skin infection  1  2/242 (0.83%)  2 4/242 (1.65%)  5 0/123 (0.00%)  0
Tooth infection  1  1/242 (0.41%)  1 5/242 (2.07%)  5 0/123 (0.00%)  0
Gastroenteritis viral  1  3/242 (1.24%)  3 1/242 (0.41%)  1 1/123 (0.81%)  1
Cellulitis  1  4/242 (1.65%)  4 0/242 (0.00%)  0 0/123 (0.00%)  0
Fungal infection  1  2/242 (0.83%)  2 2/242 (0.83%)  2 0/123 (0.00%)  0
Genital herpes  1  3/242 (1.24%)  4 1/242 (0.41%)  1 0/123 (0.00%)  0
Gingivitis  1  2/242 (0.83%)  2 2/242 (0.83%)  2 0/123 (0.00%)  0
Herpes simplex  1  4/242 (1.65%)  4 0/242 (0.00%)  0 0/123 (0.00%)  0
Hordeolum  1  1/242 (0.41%)  1 3/242 (1.24%)  4 0/123 (0.00%)  0
Tinea pedis  1  1/242 (0.41%)  1 3/242 (1.24%)  3 0/123 (0.00%)  0
Abscess  1  2/242 (0.83%)  2 1/242 (0.41%)  1 0/123 (0.00%)  0
Abscess limb  1  2/242 (0.83%)  2 1/242 (0.41%)  2 0/123 (0.00%)  0
Body tinea  1  3/242 (1.24%)  3 0/242 (0.00%)  0 0/123 (0.00%)  0
Dermatophytosis  1  2/242 (0.83%)  2 1/242 (0.41%)  2 0/123 (0.00%)  0
Ear infection  1  1/242 (0.41%)  1 2/242 (0.83%)  2 0/123 (0.00%)  0
Herpes virus infection  1  2/242 (0.83%)  2 1/242 (0.41%)  2 0/123 (0.00%)  0
Lower respiratory tract infection  1  2/242 (0.83%)  2 1/242 (0.41%)  1 0/123 (0.00%)  0
Onychomycosis  1  2/242 (0.83%)  2 0/242 (0.00%)  0 1/123 (0.81%)  1
Oral fungal infection  1  0/242 (0.00%)  0 3/242 (1.24%)  3 0/123 (0.00%)  0
Pharyngitis streptococcal  1  1/242 (0.41%)  1 2/242 (0.83%)  2 0/123 (0.00%)  0
Pneumonia  1  2/242 (0.83%)  2 1/242 (0.41%)  1 0/123 (0.00%)  0
Staphylococcal infection  1  1/242 (0.41%)  1 2/242 (0.83%)  2 0/123 (0.00%)  0
Abdominal abscess  1  1/242 (0.41%)  1 1/242 (0.41%)  2 0/123 (0.00%)  0
Acute sinusitis  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Anal abscess  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Anal chlamydia infection  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Cystitis  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Ear infection fungal  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Hepatitis C  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Infected bite  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Latent tuberculosis  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Molluscum contagiosum  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Oral candidiasis  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Papilloma viral infection  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Parainfluenzae virus infection  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Paronychia  1  1/242 (0.41%)  1 0/242 (0.00%)  0 1/123 (0.81%)  1
Periodontitis  1  2/242 (0.83%)  3 0/242 (0.00%)  0 0/123 (0.00%)  0
Proctitis gonococcal  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Rash pustular  1  1/242 (0.41%)  1 1/242 (0.41%)  2 0/123 (0.00%)  0
Respiratory tract infection viral  1  0/242 (0.00%)  0 1/242 (0.41%)  2 1/123 (0.81%)  1
Secondary syphilis  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Subcutaneous abscess  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Tinea cruris  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Tinea versicolour  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Trichomoniasis  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Urethritis chlamydial  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Urethritis gonococcal  1  1/242 (0.41%)  1 0/242 (0.00%)  0 1/123 (0.81%)  1
Viral rash  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Viral rhinitis  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Vulvovaginal candidiasis  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Vulvovaginal mycotic infection  1  0/242 (0.00%)  0 2/242 (0.83%)  3 0/123 (0.00%)  0
Anal infection  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Bacterial vaginosis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Borrelia infection  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Bronchitis viral  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Candida infection  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Carbuncle  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Chronic sinusitis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Chronic tonsillitis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Clostridium difficile colitis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Condyloma latum  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Diarrhoea infectious  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Empyema  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Enterobiasis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Escherichia urinary tract infection  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Eye infection syphilitic  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Genital candidiasis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Genitourinary chlamydia infection  1  0/242 (0.00%)  0 0/242 (0.00%)  0 1/123 (0.81%)  1
Groin abscess  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Helicobacter gastritis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Infected fistula  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Infection  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Labyrinthitis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Laryngitis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Latent syphilis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Localised infection  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Orchitis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Oropharyngeal candidiasis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Oropharyngitis fungal  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Osteomyelitis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Otitis externa  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Otitis media  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Parotitis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Peritonsillar abscess  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Pertussis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Primary syphilis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Proctitis chlamydial  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Pulmonary tuberculosis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Pyelonephritis acute  1  1/242 (0.41%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Rotavirus infection  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Salmonellosis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Shigella infection  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Sialoadenitis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Skin candida  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Strongyloidiasis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Superinfection bacterial  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Tinea capitis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Tongue fungal infection  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Tonsillitis bacterial  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Tracheitis  1  0/242 (0.00%)  0 0/242 (0.00%)  0 1/123 (0.81%)  1
Ureaplasma infection  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Vaginal infection  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Viral pharyngitis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Wound infection staphylococcal  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Injury, poisoning and procedural complications       
Arthropod bite  1  4/242 (1.65%)  4 2/242 (0.83%)  2 0/123 (0.00%)  0
Procedural pain  1  5/242 (2.07%)  5 1/242 (0.41%)  1 0/123 (0.00%)  0
Contusion  1  1/242 (0.41%)  1 4/242 (1.65%)  4 0/123 (0.00%)  0
Ligament sprain  1  4/242 (1.65%)  4 1/242 (0.41%)  1 0/123 (0.00%)  0
Hand fracture  1  2/242 (0.83%)  2 2/242 (0.83%)  3 0/123 (0.00%)  0
Animal bite  1  1/242 (0.41%)  1 2/242 (0.83%)  3 0/123 (0.00%)  0
Fall  1  1/242 (0.41%)  1 2/242 (0.83%)  2 0/123 (0.00%)  0
Laceration  1  3/242 (1.24%)  3 0/242 (0.00%)  0 0/123 (0.00%)  0
Muscle strain  1  2/242 (0.83%)  2 1/242 (0.41%)  1 0/123 (0.00%)  0
Thermal burn  1  1/242 (0.41%)  1 2/242 (0.83%)  2 0/123 (0.00%)  0
Burn oral cavity  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Foot fracture  1  1/242 (0.41%)  1 0/242 (0.00%)  0 1/123 (0.81%)  1
Joint injury  1  1/242 (0.41%)  1 0/242 (0.00%)  0 1/123 (0.81%)  1
Ligament rupture  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Meniscus injury  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Rib fracture  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Road traffic accident  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Skin abrasion  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Tooth fracture  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Arthropod sting  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Axillary nerve injury  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Back injury  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Burns first degree  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Burns second degree  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Burns third degree  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Concussion  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Corneal abrasion  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Epicondylitis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Eye injury  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Head injury  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Incision site haemorrhage  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Incision site pain  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Limb injury  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Patella fracture  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Penis injury  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Post procedural swelling  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Post-traumatic pain  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Product use complaint  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Scrotal haematoma  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Skin injury  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Sports injury  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Sunburn  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Tendon rupture  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Investigations       
Blood creatine phosphokinase increased  1  9/242 (3.72%)  9 2/242 (0.83%)  2 0/123 (0.00%)  0
Aspartate aminotransferase increased  1  2/242 (0.83%)  2 4/242 (1.65%)  4 0/123 (0.00%)  0
Blood triglycerides increased  1  1/242 (0.41%)  1 3/242 (1.24%)  3 1/123 (0.81%)  1
Weight increased  1  3/242 (1.24%)  3 2/242 (0.83%)  2 0/123 (0.00%)  0
Blood cholesterol increased  1  1/242 (0.41%)  3 3/242 (1.24%)  3 0/123 (0.00%)  0
Blood creatinine increased  1  4/242 (1.65%)  4 0/242 (0.00%)  0 0/123 (0.00%)  0
Transaminases increased  1  2/242 (0.83%)  2 2/242 (0.83%)  2 0/123 (0.00%)  0
Weight decreased  1  1/242 (0.41%)  1 3/242 (1.24%)  3 0/123 (0.00%)  0
Alanine aminotransferase increased  1  0/242 (0.00%)  0 3/242 (1.24%)  3 0/123 (0.00%)  0
Lipase increased  1  0/242 (0.00%)  0 3/242 (1.24%)  4 0/123 (0.00%)  0
Blood phosphorus decreased  1  0/242 (0.00%)  0 2/242 (0.83%)  3 0/123 (0.00%)  0
Blood testosterone decreased  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
High density lipoprotein decreased  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Blood alkaline phosphatase increased  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Blood creatine phosphokinase abnormal  1  0/242 (0.00%)  0 1/242 (0.41%)  2 0/123 (0.00%)  0
Blood creatinine abnormal  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Blood glucose increased  1  0/242 (0.00%)  0 1/242 (0.41%)  3 0/123 (0.00%)  0
Blood pressure increased  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Blood urine present  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Campylobacter test positive  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Creatinine renal clearance decreased  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Electrocardiogram abnormal  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Electrocardiogram repolarisation abnormality  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Glomerular filtration rate decreased  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Lipids increased  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Liver function test increased  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Low density lipoprotein increased  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Lymph node palpable  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Neutrophil count decreased  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Neutrophil count increased  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Parasite stool test positive  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Protein urine present  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
White blood cells urine positive  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Metabolism and nutrition disorders       
Decreased appetite  1  4/242 (1.65%)  4 8/242 (3.31%)  8 0/123 (0.00%)  0
Vitamin D deficiency  1  5/242 (2.07%)  5 5/242 (2.07%)  5 0/123 (0.00%)  0
Dyslipidaemia  1  3/242 (1.24%)  4 4/242 (1.65%)  4 0/123 (0.00%)  0
Hyperlipidaemia  1  1/242 (0.41%)  1 5/242 (2.07%)  5 0/123 (0.00%)  0
Hypercholesterolaemia  1  0/242 (0.00%)  0 5/242 (2.07%)  5 0/123 (0.00%)  0
Hypertriglyceridaemia  1  0/242 (0.00%)  0 3/242 (1.24%)  3 1/123 (0.81%)  1
Hyponatraemia  1  2/242 (0.83%)  2 1/242 (0.41%)  1 0/123 (0.00%)  0
Hypophosphataemia  1  1/242 (0.41%)  1 2/242 (0.83%)  2 0/123 (0.00%)  0
Abnormal loss of weight  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Abnormal weight gain  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Dehydration  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Diabetes mellitus  1  0/242 (0.00%)  0 0/242 (0.00%)  0 1/123 (0.81%)  1
Diabetes mellitus inadequate control  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Gout  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Hyperglycaemia  1  0/242 (0.00%)  0 0/242 (0.00%)  0 1/123 (0.81%)  1
Hyperlipasaemia  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Hypoglycaemia  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Hypokalaemia  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Hypovolaemia  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Iron deficiency  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Lipid metabolism disorder  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Metabolic acidosis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Obesity  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Type 1 diabetes mellitus  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Type 2 diabetes mellitus  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Musculoskeletal and connective tissue disorders       
Back pain  1  14/242 (5.79%)  14 17/242 (7.02%)  17 0/123 (0.00%)  0
Arthralgia  1  9/242 (3.72%)  10 15/242 (6.20%)  19 0/123 (0.00%)  0
Myalgia  1  7/242 (2.89%)  7 12/242 (4.96%)  13 1/123 (0.81%)  1
Pain in extremity  1  9/242 (3.72%)  9 9/242 (3.72%)  12 0/123 (0.00%)  0
Muscle spasms  1  3/242 (1.24%)  3 3/242 (1.24%)  3 0/123 (0.00%)  0
Neck pain  1  2/242 (0.83%)  2 4/242 (1.65%)  4 0/123 (0.00%)  0
Muscle contracture  1  3/242 (1.24%)  3 1/242 (0.41%)  1 0/123 (0.00%)  0
Osteopenia  1  3/242 (1.24%)  3 1/242 (0.41%)  1 0/123 (0.00%)  0
Tendonitis  1  3/242 (1.24%)  3 1/242 (0.41%)  1 0/123 (0.00%)  0
Flank pain  1  2/242 (0.83%)  2 1/242 (0.41%)  2 0/123 (0.00%)  0
Joint swelling  1  0/242 (0.00%)  0 3/242 (1.24%)  3 0/123 (0.00%)  0
Osteoporosis  1  1/242 (0.41%)  1 2/242 (0.83%)  2 0/123 (0.00%)  0
Pain in jaw  1  2/242 (0.83%)  2 1/242 (0.41%)  1 0/123 (0.00%)  0
Arthritis  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Bursitis  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Groin pain  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Intervertebral disc protrusion  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Musculoskeletal chest pain  1  1/242 (0.41%)  1 0/242 (0.00%)  0 1/123 (0.81%)  1
Musculoskeletal pain  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Osteoarthritis  1  1/242 (0.41%)  1 1/242 (0.41%)  1 0/123 (0.00%)  0
Spinal disorder  1  0/242 (0.00%)  0 1/242 (0.41%)  1 1/123 (0.81%)  1
Axillary mass  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Costochondritis  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Fibromyalgia  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Foot deformity  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Intervertebral disc disorder  1  0/242 (0.00%)  0 0/242 (0.00%)  0 1/123 (0.81%)  1
Joint range of motion decreased  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Joint stiffness  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Metatarsalgia  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Muscular weakness  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Musculoskeletal stiffness  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Rhabdomyolysis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Rotator cuff syndrome  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Temporomandibular joint syndrome  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Tendon disorder  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Torticollis  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)       
Anogenital warts  1  8/242 (3.31%)  10 13/242 (5.37%)  17 1/123 (0.81%)  1
Lipoma  1  2/242 (0.83%)  2 2/242 (0.83%)  2 0/123 (0.00%)  0
Melanocytic naevus  1  1/242 (0.41%)  1 3/242 (1.24%)  3 0/123 (0.00%)  0
Basal cell carcinoma  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Seborrhoeic keratosis  1  0/242 (0.00%)  0 2/242 (0.83%)  3 0/123 (0.00%)  0
Skin papilloma  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Acrochordon  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Fibroma  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Oral neoplasm  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0
Papilloma  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Squamous cell carcinoma of skin  1  1/242 (0.41%)  1 0/242 (0.00%)  0 0/123 (0.00%)  0
Nervous system disorders       
Headache  1  40/242 (16.53%)  45 26/242 (10.74%)  29 2/123 (1.63%)  2
Dizziness  1  14/242 (5.79%)  15 13/242 (5.37%)  14 0/123 (0.00%)  0
Hypoaesthesia  1  4/242 (1.65%)  4 2/242 (0.83%)  2 0/123 (0.00%)  0
Paraesthesia  1  1/242 (0.41%)  1 4/242 (1.65%)  5 0/123 (0.00%)  0
Sciatica  1  4/242 (1.65%)  4 0/242 (0.00%)  0 1/123 (0.81%)  1
Somnolence  1  2/242 (0.83%)  2 3/242 (1.24%)  3 0/123 (0.00%)  0
Migraine  1  0/242 (0.00%)  0 4/242 (1.65%)  4 0/123 (0.00%)  0
Balance disorder  1  0/242 (0.00%)  0 3/242 (1.24%)  3 0/123 (0.00%)  0
Memory impairment  1  1/242 (0.41%)  1 2/242 (0.83%)  2 0/123 (0.00%)  0
Syncope  1  2/242 (0.83%)  2 1/242 (0.41%)  1 0/123 (0.00%)  0
Carpal tunnel syndrome  1  2/242 (0.83%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Dysgeusia  1  0/242 (0.00%)  0 2/242 (0.83%)  2 0/123 (0.00%)  0
Burning sensation  1  1/242 (0.41%)  2 0/242 (0.00%)  0 0/123 (0.00%)  0
Cervicobrachial syndrome  1  0/242 (0.00%)  0 1/242 (0.41%)  1 0/123 (0.00%)  0