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Combination Therapy for Chronic Hepatitis C Infection

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ClinicalTrials.gov Identifier: NCT01805882
Recruitment Status : Completed
First Posted : March 6, 2013
Results First Posted : April 11, 2017
Last Update Posted : June 8, 2017
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C, Chronic
Interventions Drug: Sofosbuvir
Drug: Ledipasvir
Drug: GS-9669
Drug: GS-9451
Enrollment 229

Recruitment Details  
Pre-assignment Details  
Arm/Group Title A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669 C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451 D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451 G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451 H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
Hide Arm/Group Description Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
Period Title: Overall Study
Started 20 20 20 34 14 21 50 25 25
Completed 20 20 19 32 14 20 48 25 24
Not Completed 0 0 1 2 0 1 2 0 1
Arm/Group Title A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669 C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451 D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451 G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451 H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669 Total
Hide Arm/Group Description Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease Total of all reporting groups
Overall Number of Baseline Participants 20 20 20 34 14 21 50 25 25 229
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 34 participants 14 participants 21 participants 50 participants 25 participants 25 participants 229 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
19
  95.0%
19
  95.0%
19
  95.0%
27
  79.4%
11
  78.6%
19
  90.5%
48
  96.0%
24
  96.0%
19
  76.0%
205
  89.5%
>=65 years
1
   5.0%
1
   5.0%
1
   5.0%
7
  20.6%
3
  21.4%
2
   9.5%
2
   4.0%
1
   4.0%
6
  24.0%
24
  10.5%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 34 participants 14 participants 21 participants 50 participants 25 participants 25 participants 229 participants
Female
6
  30.0%
8
  40.0%
4
  20.0%
6
  17.6%
1
   7.1%
7
  33.3%
17
  34.0%
8
  32.0%
6
  24.0%
63
  27.5%
Male
14
  70.0%
12
  60.0%
16
  80.0%
28
  82.4%
13
  92.9%
14
  66.7%
33
  66.0%
17
  68.0%
19
  76.0%
166
  72.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 34 participants 14 participants 21 participants 50 participants 25 participants 25 participants 229 participants
Hispanic or Latino
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
3
   6.0%
1
   4.0%
0
   0.0%
5
   2.2%
Not Hispanic or Latino
19
  95.0%
20
 100.0%
20
 100.0%
34
 100.0%
14
 100.0%
21
 100.0%
46
  92.0%
24
  96.0%
25
 100.0%
223
  97.4%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.0%
0
   0.0%
0
   0.0%
1
   0.4%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants 20 participants 20 participants 34 participants 14 participants 21 participants 50 participants 25 participants 25 participants 229 participants
American Indian or Alaska Native
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
1
   4.8%
0
   0.0%
0
   0.0%
0
   0.0%
2
   0.9%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
15
  75.0%
19
  95.0%
18
  90.0%
28
  82.4%
13
  92.9%
9
  42.9%
29
  58.0%
19
  76.0%
19
  76.0%
169
  73.8%
White
3
  15.0%
1
   5.0%
2
  10.0%
5
  14.7%
1
   7.1%
11
  52.4%
17
  34.0%
4
  16.0%
5
  20.0%
49
  21.4%
More than one race
1
   5.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2
   4.0%
1
   4.0%
0
   0.0%
4
   1.7%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
1
   2.9%
0
   0.0%
0
   0.0%
2
   4.0%
1
   4.0%
1
   4.0%
5
   2.2%
1.Primary Outcome
Title The Proportion of Subjects Who Achieve Sustained Viral Response (SVR12) 12 Weeks After the Stop of Treatment Drugs
Hide Description The primary outcome was the proportion of patients with sustained viral response measured 12 weeks after the stop of treatment. The viral response was assessed by serum HCV RNA concentrations lower than 43 IU/mL - the lower limit of quantification.
Time Frame 12 weeks after stop of treatment
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects who received treatment drugs per arm as listed in the Outcome Measure Description
Arm/Group Title A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669 C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451 D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451 G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451 H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
Hide Arm/Group Description:
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients
Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects
Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease
Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
Overall Number of Participants Analyzed 20 20 20 34 14 21 50 25 25
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
100
(83 to 100)
95
(75 to 100)
95
(75 to 100)
91.2
(76 to 98)
100
(83 to 100)
95
(76 to 100)
76
(60 to 85)
40
(21 to 61)
20
(7 to 41)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669 C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451 D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451 G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451 H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
Hide Arm/Group Description Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment naïve patients Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9669 500mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients Oral treatment with Sofosbuvir 400mg (GS-7977), Ledipasvir 90mg (GS-5885), GS-9451 80mg, once daily, for 6 weeks in HCV genotype 1, treatment naïve patients Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 1 subjects who failed HCV therapy in Arm B or Arm G or Arm H Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, for 12 weeks in HCV genotype 1, treatment-relapsed patients who previously received Sofosbuvir plus Ribavirin Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885), once daily, 12 weeks in HCV genotype 4 treatment naïve subjects and interferon treament experienced subjects Oral treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) and GS-9451 80mg, once daily, 6 weeks in HCV genotype 1 treatment naïve and treatment experienced subjects with advanced liver disease Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease Oral Treatment with Sofosbuvir 400mg (GS-7977) and Ledipasvir 90mg (GS-5885) with GS-9451 80mg, and GS-9669 250mg, once daily, 4 weeks in HCV genotype 1 treatment naïve subjects with early stage liver disease
All-Cause Mortality
A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669 C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451 D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451 G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451 H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669 C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451 D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451 G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451 H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/20 (0.00%)   0/20 (0.00%)   2/20 (10.00%)   1/34 (2.94%)   1/14 (7.14%)   0/21 (0.00%)   2/50 (4.00%)   0/25 (0.00%)   1/25 (4.00%) 
Cardiac disorders                   
Angina pectoris   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Bradycardia   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  1/25 (4.00%) 
Ear and labyrinth disorders                   
Vertigo   0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Gastrointestinal disorders                   
Colitis   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
General disorders                   
Pain   0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Infections and infestations                   
Influenza   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  1/14 (7.14%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Injury, poisoning and procedural complications                   
Transfusion reaction   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Investigations                   
Haemoglobin decreased   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
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%
A: HCV GT-1, tx Naive, 12 Wks Sofosbuvir/Ledipasvir B: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9669 C: HCV GT-1, tx Naive, 6 Wks Sofosbuvir/Ledipasvir/GS-9451 D Retx: HCV GT-1, Re-Treatment, 12 Wks Sofosbuvir, Ledipasvir D: HCV GT-1, Tx-relapsed, 12 Wks Sofosbuvir/Ledipasvir E: HCV GT-4, tx Naive/Expd, 12 Wks Sofosbuvir/Ledipasvir F: HCV GT-1, tx Naive/Expd 6 Wks Sofosbuvir/Ledipasvir/GS-9451 G: HCV GT-1, tx Naive, 4 Wks Sofosbuvir, Ledipasvir, GS-9451 H: HCV GT-1, tx Naive, 4 Wks Sofos/Ledip/GS-9451/GS-9669
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   17/20 (85.00%)   20/20 (100.00%)   20/20 (100.00%)   34/34 (100.00%)   14/14 (100.00%)   17/21 (80.95%)   48/50 (96.00%)   24/25 (96.00%)   25/25 (100.00%) 
Cardiac disorders                   
Coronary artery disease   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Ear and labyrinth disorders                   
Ear pain   1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Vertigo   0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Eye disorders                   
Conjunctival haemorrhage   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Lacrimation increased   0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Gastrointestinal disorders                   
Abdominal distension   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  2/25 (8.00%) 
Abdominal pain   1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  4/25 (16.00%) 
Abdominal tenderness   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  1/25 (4.00%) 
Constipation   0/20 (0.00%)  2/20 (10.00%)  1/20 (5.00%)  2/34 (5.88%)  1/14 (7.14%)  0/21 (0.00%)  3/50 (6.00%)  3/25 (12.00%)  3/25 (12.00%) 
Diarrhoea   1/20 (5.00%)  6/20 (30.00%)  3/20 (15.00%)  0/34 (0.00%)  1/14 (7.14%)  3/21 (14.29%)  4/50 (8.00%)  1/25 (4.00%)  5/25 (20.00%) 
Dry mouth   0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/34 (0.00%)  0/14 (0.00%)  1/21 (4.76%)  1/50 (2.00%)  4/25 (16.00%)  3/25 (12.00%) 
Dyspepsia   0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/34 (0.00%)  0/14 (0.00%)  1/21 (4.76%)  0/50 (0.00%)  0/25 (0.00%)  1/25 (4.00%) 
Flatulence   0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/34 (0.00%)  1/14 (7.14%)  0/21 (0.00%)  2/50 (4.00%)  0/25 (0.00%)  0/25 (0.00%) 
Gastritis   1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Nausea   0/20 (0.00%)  2/20 (10.00%)  2/20 (10.00%)  1/34 (2.94%)  0/14 (0.00%)  2/21 (9.52%)  5/50 (10.00%)  0/25 (0.00%)  8/25 (32.00%) 
Peptic ulcer   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Stomatitis   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  1/25 (4.00%) 
Vomiting   1/20 (5.00%)  2/20 (10.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  3/50 (6.00%)  0/25 (0.00%)  0/25 (0.00%) 
General disorders                   
Face oedema   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Fatigue   1/20 (5.00%)  2/20 (10.00%)  4/20 (20.00%)  2/34 (5.88%)  0/14 (0.00%)  3/21 (14.29%)  6/50 (12.00%)  4/25 (16.00%)  4/25 (16.00%) 
Influenza like illness   0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Localised oedema   0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  2/21 (9.52%)  0/50 (0.00%)  1/25 (4.00%)  1/25 (4.00%) 
Non-cardiac chest pain   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Oedema peripheral   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Pain   2/20 (10.00%)  2/20 (10.00%)  1/20 (5.00%)  0/34 (0.00%)  0/14 (0.00%)  1/21 (4.76%)  1/50 (2.00%)  1/25 (4.00%)  0/25 (0.00%) 
Pyrexia   0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Immune system disorders                   
Hypersensitivity   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Seasonal allergy   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  1/25 (4.00%)  0/25 (0.00%) 
Infections and infestations                   
Bronchitis   1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Cellulitis   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  2/50 (4.00%)  1/25 (4.00%)  0/25 (0.00%) 
Chlamydial infection   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  1/21 (4.76%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Diarrhoea infectious   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  1/25 (4.00%)  0/25 (0.00%) 
Herpes zoster   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  1/14 (7.14%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Hordeolum   0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Nasopharyngitis   4/20 (20.00%)  1/20 (5.00%)  1/20 (5.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  3/50 (6.00%)  1/25 (4.00%)  0/25 (0.00%) 
Sinusitis   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Staphylococcal infection   1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Tooth infection   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Upper respiratory tract infection   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  2/21 (9.52%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Urethritis trichomonal   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Urinary tract infection   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  2/34 (5.88%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Vaginitis bacterial   0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Wound infection   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Injury, poisoning and procedural complications                   
Arthropod bite   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Injury   0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Laceration   0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Muscle strain   1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  1/25 (4.00%)  1/25 (4.00%) 
Investigations                   
Activated partial thromboplastin time prolonged   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  2/50 (4.00%)  1/25 (4.00%)  1/25 (4.00%) 
Alanine aminotransferase increased   1/20 (5.00%)  2/20 (10.00%)  0/20 (0.00%)  2/34 (5.88%)  0/14 (0.00%)  0/21 (0.00%)  8/50 (16.00%)  1/25 (4.00%)  1/25 (4.00%) 
Amylase increased   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  5/34 (14.71%)  0/14 (0.00%)  1/21 (4.76%)  11/50 (22.00%)  3/25 (12.00%)  1/25 (4.00%) 
Aspartate aminotransferase increased   2/20 (10.00%)  2/20 (10.00%)  2/20 (10.00%)  3/34 (8.82%)  0/14 (0.00%)  0/21 (0.00%)  9/50 (18.00%)  2/25 (8.00%)  2/25 (8.00%) 
Blood alkaline phosphatase increased   0/20 (0.00%)  2/20 (10.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  2/21 (9.52%)  1/50 (2.00%)  0/25 (0.00%)  1/25 (4.00%) 
Blood bicarbonate abnormal   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  2/34 (5.88%)  1/14 (7.14%)  0/21 (0.00%)  4/50 (8.00%)  0/25 (0.00%)  1/25 (4.00%) 
Blood bilirubin increased   0/20 (0.00%)  1/20 (5.00%)  5/20 (25.00%)  0/34 (0.00%)  1/14 (7.14%)  2/21 (9.52%)  2/50 (4.00%)  0/25 (0.00%)  3/25 (12.00%) 
Blood cholesterol increased   4/20 (20.00%)  3/20 (15.00%)  3/20 (15.00%)  17/34 (50.00%)  3/14 (21.43%)  5/21 (23.81%)  4/50 (8.00%)  7/25 (28.00%)  5/25 (20.00%) 
Blood creatine phosphokinase increased   2/20 (10.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Blood creatinine increased   0/20 (0.00%)  1/20 (5.00%)  4/20 (20.00%)  6/34 (17.65%)  2/14 (14.29%)  3/21 (14.29%)  1/50 (2.00%)  1/25 (4.00%)  0/25 (0.00%) 
Haemoglobin decreased   0/20 (0.00%)  1/20 (5.00%)  3/20 (15.00%)  0/34 (0.00%)  0/14 (0.00%)  1/21 (4.76%)  6/50 (12.00%)  0/25 (0.00%)  0/25 (0.00%) 
Lipase increased   1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  1/14 (7.14%)  2/21 (9.52%)  4/50 (8.00%)  0/25 (0.00%)  1/25 (4.00%) 
Low density lipoprotein increased   2/20 (10.00%)  2/20 (10.00%)  0/20 (0.00%)  10/34 (29.41%)  3/14 (21.43%)  5/21 (23.81%)  3/50 (6.00%)  5/25 (20.00%)  4/25 (16.00%) 
Lymphocyte count decreased   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  1/21 (4.76%)  2/50 (4.00%)  0/25 (0.00%)  0/25 (0.00%) 
Neutrophil count decreased   4/20 (20.00%)  1/20 (5.00%)  1/20 (5.00%)  3/34 (8.82%)  1/14 (7.14%)  2/21 (9.52%)  3/50 (6.00%)  2/25 (8.00%)  3/25 (12.00%) 
Platelet count decreased   3/20 (15.00%)  1/20 (5.00%)  2/20 (10.00%)  1/34 (2.94%)  0/14 (0.00%)  2/21 (9.52%)  5/50 (10.00%)  0/25 (0.00%)  0/25 (0.00%) 
Tuberculin test positive   1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  1/14 (7.14%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
White blood cell count decreased   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  1/21 (4.76%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Metabolism and nutrition disorders                   
Decreased appetite   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  1/25 (4.00%)  0/25 (0.00%) 
Diabetes mellitus   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Hypercalcaemia   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  4/34 (11.76%)  0/14 (0.00%)  1/21 (4.76%)  3/50 (6.00%)  2/25 (8.00%)  2/25 (8.00%) 
Hyperglycaemia   6/20 (30.00%)  9/20 (45.00%)  9/20 (45.00%)  12/34 (35.29%)  6/14 (42.86%)  8/21 (38.10%)  20/50 (40.00%)  6/25 (24.00%)  9/25 (36.00%) 
Hyperkalaemia   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  1/25 (4.00%) 
Hypernatraemia   1/20 (5.00%)  0/20 (0.00%)  1/20 (5.00%)  4/34 (11.76%)  0/14 (0.00%)  0/21 (0.00%)  2/50 (4.00%)  2/25 (8.00%)  6/25 (24.00%) 
Hypoalbuminaemia   4/20 (20.00%)  8/20 (40.00%)  8/20 (40.00%)  0/34 (0.00%)  2/14 (14.29%)  2/21 (9.52%)  3/50 (6.00%)  0/25 (0.00%)  1/25 (4.00%) 
Hypocalcaemia   0/20 (0.00%)  0/20 (0.00%)  2/20 (10.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Hypoglycaemia   2/20 (10.00%)  1/20 (5.00%)  0/20 (0.00%)  4/34 (11.76%)  1/14 (7.14%)  2/21 (9.52%)  4/50 (8.00%)  3/25 (12.00%)  1/25 (4.00%) 
Hypokalaemia   1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  4/34 (11.76%)  0/14 (0.00%)  1/21 (4.76%)  2/50 (4.00%)  1/25 (4.00%)  3/25 (12.00%) 
Hypomagnesaemia   1/20 (5.00%)  1/20 (5.00%)  3/20 (15.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Hyponatraemia   0/20 (0.00%)  1/20 (5.00%)  1/20 (5.00%)  0/34 (0.00%)  1/14 (7.14%)  0/21 (0.00%)  3/50 (6.00%)  2/25 (8.00%)  0/25 (0.00%) 
Hypophosphataemia   7/20 (35.00%)  6/20 (30.00%)  4/20 (20.00%)  8/34 (23.53%)  2/14 (14.29%)  6/21 (28.57%)  5/50 (10.00%)  4/25 (16.00%)  0/25 (0.00%) 
Musculoskeletal and connective tissue disorders                   
Arthralgia   2/20 (10.00%)  0/20 (0.00%)  1/20 (5.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  1/25 (4.00%)  1/25 (4.00%) 
Back pain   1/20 (5.00%)  0/20 (0.00%)  1/20 (5.00%)  0/34 (0.00%)  1/14 (7.14%)  0/21 (0.00%)  0/50 (0.00%)  1/25 (4.00%)  0/25 (0.00%) 
Flank pain   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Muscle spasms   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  1/25 (4.00%)  1/25 (4.00%) 
Musculoskeletal stiffness   1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Myalgia   1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  1/14 (7.14%)  1/21 (4.76%)  3/50 (6.00%)  0/25 (0.00%)  1/25 (4.00%) 
Neck pain   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  1/25 (4.00%) 
Osteoporosis   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Pain in extremity   1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Nervous system disorders                   
Dizziness   1/20 (5.00%)  2/20 (10.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  3/50 (6.00%)  1/25 (4.00%)  6/25 (24.00%) 
Headache   5/20 (25.00%)  5/20 (25.00%)  0/20 (0.00%)  1/34 (2.94%)  2/14 (14.29%)  2/21 (9.52%)  4/50 (8.00%)  1/25 (4.00%)  7/25 (28.00%) 
Hypoaesthesia   0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Somnolence   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  1/25 (4.00%) 
Tension headache   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Tremor   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  1/21 (4.76%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Psychiatric disorders                   
Affective disorder   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  1/25 (4.00%) 
Alcohol abuse   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Anxiety   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Depression   0/20 (0.00%)  0/20 (0.00%)  1/20 (5.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Drug abuse   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Insomnia   1/20 (5.00%)  1/20 (5.00%)  1/20 (5.00%)  0/34 (0.00%)  0/14 (0.00%)  1/21 (4.76%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Irritability   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Renal and urinary disorders                   
Dysuria   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Micturition urgency   1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Pollakiuria   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  1/25 (4.00%) 
Polyuria   0/20 (0.00%)  1/20 (5.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Reproductive system and breast disorders                   
Balanoposthitis   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Postmenopausal haemorrhage   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Spermatocele   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Vaginal discharge   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  1/25 (4.00%) 
Respiratory, thoracic and mediastinal disorders                   
Cough   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Dysphonia   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  1/25 (4.00%)  0/25 (0.00%) 
Epistaxis   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Nasal congestion   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  1/14 (7.14%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Oropharyngeal pain   0/20 (0.00%)  1/20 (5.00%)  1/20 (5.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Productive cough   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Rhinitis allergic   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Sleep apnoea syndrome   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  1/21 (4.76%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Skin and subcutaneous tissue disorders                   
Acute generalised exanthematous pustulosis   1/20 (5.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Dry skin   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Night sweats   0/20 (0.00%)  2/20 (10.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Pruritus   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Rash   2/20 (10.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Rash maculo-papular   1/20 (5.00%)  1/20 (5.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Rash pruritic   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  1/14 (7.14%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Skin lesion   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  1/21 (4.76%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Social circumstances                   
Ex-tobacco user   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Surgical and medical procedures                   
Supplementation therapy   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  0/50 (0.00%)  0/25 (0.00%)  0/25 (0.00%) 
Surgery   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Tooth extraction   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  1/34 (2.94%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Transfusion   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Vascular disorders                   
Hot flush   0/20 (0.00%)  0/20 (0.00%)  0/20 (0.00%)  0/34 (0.00%)  0/14 (0.00%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Hypertension   1/20 (5.00%)  0/20 (0.00%)  1/20 (5.00%)  2/34 (5.88%)  1/14 (7.14%)  0/21 (0.00%)  1/50 (2.00%)  0/25 (0.00%)  0/25 (0.00%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Shyam Kottilil MD
Organization: National Institute of Allergy and Infectious Diseases
Phone: +1 410 706 4872
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: National Institutes of Health Clinical Center (CC) ( National Institute of Allergy and Infectious Diseases (NIAID) )
ClinicalTrials.gov Identifier: NCT01805882     History of Changes
Other Study ID Numbers: 130066
13-I-0066 ( Other Identifier: NIH )
First Submitted: March 5, 2013
First Posted: March 6, 2013
Results First Submitted: February 28, 2017
Results First Posted: April 11, 2017
Last Update Posted: June 8, 2017