Trial Outcomes & Findings for Evaluating the Safety and Tolerability of Antiretroviral Drug Regimens Used as Pre-Exposure Prophylaxis to Prevent HIV Infection in At-Risk Men Who Have Sex With Men and in At-Risk Women (NCT NCT01505114)
NCT ID: NCT01505114
Last Updated: 2021-11-05
Results Overview
participants had Occurrence of Grade 3 or higher adverse events (AEs)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
594 participants
Primary outcome timeframe
Through Week 48
Results posted on
2021-11-05
Participant Flow
The study started the enrollment in June 2012. Accrual will occur in a staggered fashion, with men beginning first and women beginning several months later. Accrual for the men will occur over approximately 9 months, and accrual for the women will require approximately 9 months.
Exclusion--reactive HIV test results;Co-enrollment in any other HIV interventional research study; Use of ARV therapy; Prior history of any procedure altering the gastrointestinal tract or drug absorption; Receipt of prohibited medications; Known allergy to soy/peanuts; Weight\>300 lbs;
Participant milestones
| Measure |
MVC Only
MVC 300 mg plus FTC placebo and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48
|
MVC + FTC
MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48
|
MVC + TDF
MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48
|
TDF + FTC
MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Maraviroc placebo: Once daily from Week 0 through Week 48
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
148
|
148
|
147
|
151
|
|
Overall Study
COMPLETED
|
123
|
135
|
129
|
128
|
|
Overall Study
NOT COMPLETED
|
25
|
13
|
18
|
23
|
Reasons for withdrawal
| Measure |
MVC Only
MVC 300 mg plus FTC placebo and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48
|
MVC + FTC
MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48
|
MVC + TDF
MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48
|
TDF + FTC
MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Maraviroc placebo: Once daily from Week 0 through Week 48
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
4
|
4
|
7
|
|
Overall Study
Death
|
1
|
0
|
0
|
1
|
|
Overall Study
unable to adhere to visit schedule
|
3
|
2
|
3
|
3
|
|
Overall Study
Lost to Follow-up
|
11
|
5
|
8
|
7
|
|
Overall Study
relocated
|
4
|
2
|
2
|
3
|
|
Overall Study
inadvertent enrollment due to peanut all
|
0
|
0
|
0
|
1
|
|
Overall Study
staff safety concerns
|
0
|
0
|
0
|
1
|
|
Overall Study
investigator decision
|
1
|
0
|
1
|
0
|
Baseline Characteristics
analysis for men
Baseline characteristics by cohort
| Measure |
Arm 1
n=147 Participants
MVC 300 mg plus FTC placebo and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48
|
Arm 2
n=151 Participants
MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48
|
Arm 3
n=148 Participants
MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48
|
Arm 4
n=148 Participants
MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Maraviroc placebo: Once daily from Week 0 through Week 48
|
Total
n=594 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
30 years
n=101 Participants • analysis for men
|
29.5 years
n=106 Participants • analysis for men
|
30 years
n=99 Participants • analysis for men
|
31 years
n=100 Participants • analysis for men
|
30 years
n=406 Participants • analysis for men
|
|
Age, Continuous
Women
|
40 years
n=46 Participants • Analysis for women
|
36 years
n=45 Participants • Analysis for women
|
37 years
n=49 Participants • Analysis for women
|
37 years
n=48 Participants • Analysis for women
|
36 years
n=188 Participants • Analysis for women
|
|
Sex: Female, Male
Female
|
46 Participants
n=147 Participants
|
45 Participants
n=151 Participants
|
49 Participants
n=148 Participants
|
48 Participants
n=148 Participants
|
188 Participants
n=594 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=147 Participants
|
106 Participants
n=151 Participants
|
99 Participants
n=148 Participants
|
100 Participants
n=148 Participants
|
406 Participants
n=594 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan Native
|
4 Participants
n=147 Participants
|
6 Participants
n=151 Participants
|
2 Participants
n=148 Participants
|
5 Participants
n=148 Participants
|
17 Participants
n=594 Participants
|
|
Race/Ethnicity, Customized
Asian
|
6 Participants
n=147 Participants
|
1 Participants
n=151 Participants
|
5 Participants
n=148 Participants
|
5 Participants
n=148 Participants
|
17 Participants
n=594 Participants
|
|
Race/Ethnicity, Customized
Black or African
|
61 Participants
n=147 Participants
|
64 Participants
n=151 Participants
|
62 Participants
n=148 Participants
|
51 Participants
n=148 Participants
|
238 Participants
n=594 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Pacific Islander
|
1 Participants
n=147 Participants
|
2 Participants
n=151 Participants
|
1 Participants
n=148 Participants
|
3 Participants
n=148 Participants
|
7 Participants
n=594 Participants
|
|
Race/Ethnicity, Customized
White
|
73 Participants
n=147 Participants
|
80 Participants
n=151 Participants
|
72 Participants
n=148 Participants
|
78 Participants
n=148 Participants
|
303 Participants
n=594 Participants
|
|
Race/Ethnicity, Customized
Other
|
15 Participants
n=147 Participants
|
14 Participants
n=151 Participants
|
10 Participants
n=148 Participants
|
16 Participants
n=148 Participants
|
55 Participants
n=594 Participants
|
|
education
8th Grade or Less
|
1 Participants
n=147 Participants
|
3 Participants
n=151 Participants
|
0 Participants
n=148 Participants
|
1 Participants
n=148 Participants
|
5 Participants
n=594 Participants
|
|
education
Some High School
|
10 Participants
n=147 Participants
|
7 Participants
n=151 Participants
|
6 Participants
n=148 Participants
|
9 Participants
n=148 Participants
|
32 Participants
n=594 Participants
|
|
education
High School Graduate or Equivalent
|
35 Participants
n=147 Participants
|
27 Participants
n=151 Participants
|
25 Participants
n=148 Participants
|
27 Participants
n=148 Participants
|
114 Participants
n=594 Participants
|
|
education
Vocational/Trade/Technical School
|
3 Participants
n=147 Participants
|
7 Participants
n=151 Participants
|
7 Participants
n=148 Participants
|
6 Participants
n=148 Participants
|
23 Participants
n=594 Participants
|
|
education
Some College or 2 Year Degree
|
51 Participants
n=147 Participants
|
43 Participants
n=151 Participants
|
57 Participants
n=148 Participants
|
55 Participants
n=148 Participants
|
206 Participants
n=594 Participants
|
|
education
Finished College
|
37 Participants
n=147 Participants
|
40 Participants
n=151 Participants
|
36 Participants
n=148 Participants
|
40 Participants
n=148 Participants
|
153 Participants
n=594 Participants
|
|
education
masters or other advanced degree
|
10 Participants
n=147 Participants
|
24 Participants
n=151 Participants
|
17 Participants
n=148 Participants
|
10 Participants
n=148 Participants
|
61 Participants
n=594 Participants
|
|
Marital Status
Married/Civil Union/Legal Partnership
|
8 Participants
n=147 Participants
|
9 Participants
n=151 Participants
|
7 Participants
n=148 Participants
|
14 Participants
n=148 Participants
|
38 Participants
n=594 Participants
|
|
Marital Status
Living with Primary Partner
|
25 Participants
n=147 Participants
|
21 Participants
n=151 Participants
|
25 Participants
n=148 Participants
|
21 Participants
n=148 Participants
|
92 Participants
n=594 Participants
|
|
Marital Status
Not Living with Primary Partner
|
12 Participants
n=147 Participants
|
17 Participants
n=151 Participants
|
19 Participants
n=148 Participants
|
14 Participants
n=148 Participants
|
62 Participants
n=594 Participants
|
|
Marital Status
Single/Divorced/Widowed
|
102 Participants
n=147 Participants
|
103 Participants
n=151 Participants
|
96 Participants
n=148 Participants
|
98 Participants
n=148 Participants
|
399 Participants
n=594 Participants
|
|
Marital Status
Other
|
0 Participants
n=147 Participants
|
1 Participants
n=151 Participants
|
1 Participants
n=148 Participants
|
1 Participants
n=148 Participants
|
3 Participants
n=594 Participants
|
|
Employment Status
Full-time Employment
|
56 Participants
n=147 Participants
|
68 Participants
n=151 Participants
|
59 Participants
n=148 Participants
|
74 Participants
n=148 Participants
|
257 Participants
n=594 Participants
|
|
Employment Status
Part-time Employment
|
38 Participants
n=147 Participants
|
35 Participants
n=151 Participants
|
36 Participants
n=148 Participants
|
25 Participants
n=148 Participants
|
134 Participants
n=594 Participants
|
|
Employment Status
Not Employed
|
53 Participants
n=147 Participants
|
48 Participants
n=151 Participants
|
52 Participants
n=148 Participants
|
49 Participants
n=148 Participants
|
202 Participants
n=594 Participants
|
PRIMARY outcome
Timeframe: Through Week 48participants had Occurrence of Grade 3 or higher adverse events (AEs)
Outcome measures
| Measure |
Arm 1
n=147 Participants
MVC 300 mg plus FTC placebo and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48
|
Arm 2
n=151 Participants
MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48
|
Arm 3
n=148 Participants
MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48
|
Arm 4
n=148 Participants
MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Maraviroc placebo: Once daily from Week 0 through Week 48
|
|---|---|---|---|---|
|
Occurrence of Grade 3 or Higher Adverse Events (AEs)
|
18 Participants
|
24 Participants
|
20 Participants
|
28 Participants
|
Adverse Events
Arm 1
Serious events: 10 serious events
Other events: 78 other events
Deaths: 0 deaths
Arm 2
Serious events: 5 serious events
Other events: 86 other events
Deaths: 1 deaths
Arm 3
Serious events: 4 serious events
Other events: 84 other events
Deaths: 1 deaths
Arm 4
Serious events: 11 serious events
Other events: 91 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm 1
n=147 participants at risk
MVC 300 mg plus FTC placebo and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48
|
Arm 2
n=151 participants at risk
MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48
|
Arm 3
n=148 participants at risk
MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48
|
Arm 4
n=148 participants at risk
MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Maraviroc placebo: Once daily from Week 0 through Week 48
|
|---|---|---|---|---|
|
Cardiac disorders
Cardiac arrest
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Cardiac disorders
Cardiac failure congestive
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Cardiac disorders
Myocardial infarction
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Congenital, familial and genetic disorders
Congenital anomaly in offspring
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
General disorders
Malaise
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Immune system disorders
Hypersensitivity
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Appendicitis perforated
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Chikungunya virus infection
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Influenza
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Pneumonia streptococcal
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Staphylococcal skin infection
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Toxicity to various agents
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Clear cell renal cell carcinoma
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Nervous system disorders
Seizure
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion late
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Psychiatric disorders
Completed suicide
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Psychiatric disorders
Depression
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Psychiatric disorders
Major depression
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Psychiatric disorders
Suicidal ideation
|
0.68%
1/147 • Number of events 2 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax spontaneous
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
Other adverse events
| Measure |
Arm 1
n=147 participants at risk
MVC 300 mg plus FTC placebo and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48
|
Arm 2
n=151 participants at risk
MVC 300 mg plus FTC 200 mg and TDF placebo orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate placebo: Once daily from Week 0 through Week 48
|
Arm 3
n=148 participants at risk
MVC 300 mg plus FTC placebo and TDF 300 mg orally once daily
Maraviroc: 300-mg tablet, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Emtricitabine placebo: Once daily from Week 0 through Week 48
|
Arm 4
n=148 participants at risk
MVC placebo plus FTC 200 mg and TDF 300 mg orally once daily
Emtricitabine: 200-mg capsule, once daily, from Week 0 through Week 48
Tenofovir disoproxil fumarate: 300-mg tablet, once daily, from Week 0 through Week 48
Maraviroc placebo: Once daily from Week 0 through Week 48
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
2.7%
4/148 • Number of events 5 • 49 weeks
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Congenital, familial and genetic disorders
Gilbert's syndrome
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Ear and labyrinth disorders
Ear pain
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Ear and labyrinth disorders
Motion sickness
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Ear and labyrinth disorders
Tympanic membrane perforation
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Ear and labyrinth disorders
Vertigo
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Endocrine disorders
Hypothyroidism
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Eye disorders
Dry eye
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Eye disorders
Eye irritation
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Eye disorders
Eye pruritus
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Eye disorders
Eye swelling
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Eye disorders
Ocular hyperaemia
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Eye disorders
Retinal detachment
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Eye disorders
Vision blurred
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Gastrointestinal disorders
Abdominal distension
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Gastrointestinal disorders
Abdominal pain
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
|
Gastrointestinal disorders
Anal fissure
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Gastrointestinal disorders
Anogenital dysplasia
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 2 • 49 weeks
|
|
Gastrointestinal disorders
Anorectal disorder
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Gastrointestinal disorders
Constipation
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
2.0%
3/151 • Number of events 3 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Gastrointestinal disorders
Dental caries
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Gastrointestinal disorders
Diarrhoea
|
8.8%
13/147 • Number of events 13 • 49 weeks
|
4.0%
6/151 • Number of events 6 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
5.4%
8/148 • Number of events 11 • 49 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
1.4%
2/148 • Number of events 3 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Gastrointestinal disorders
Dysphagia
|
0.68%
1/147 • Number of events 2 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Gastrointestinal disorders
Faeces soft
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Gastrointestinal disorders
Flatulence
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Gastrointestinal disorders
Food poisoning
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
|
Gastrointestinal disorders
Gingival recession
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Gastrointestinal disorders
Haematochezia
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
|
Gastrointestinal disorders
Lip swelling
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Gastrointestinal disorders
Nausea
|
4.8%
7/147 • Number of events 7 • 49 weeks
|
4.0%
6/151 • Number of events 6 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
3.4%
5/148 • Number of events 6 • 49 weeks
|
|
Gastrointestinal disorders
Oesophageal ulcer
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Gastrointestinal disorders
Rectal discharge
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Gastrointestinal disorders
Rectal tenesmus
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Gastrointestinal disorders
Toothache
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
3/147 • Number of events 3 • 49 weeks
|
2.6%
4/151 • Number of events 4 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
|
General disorders
Chest pain
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
General disorders
Chills
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
General disorders
Early satiety
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
General disorders
Face oedema
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
General disorders
Fat tissue increased
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
General disorders
Fatigue
|
2.7%
4/147 • Number of events 4 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
General disorders
Influenza like illness
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
2.0%
3/151 • Number of events 3 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
2.7%
4/148 • Number of events 4 • 49 weeks
|
|
General disorders
Malaise
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
General disorders
Pain
|
0.68%
1/147 • Number of events 2 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
General disorders
Pyrexia
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
2.6%
4/151 • Number of events 4 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Hepatobiliary disorders
Hepatic steatosis
|
0.68%
1/147 • Number of events 3 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
|
Immune system disorders
Allergy to animal
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Immune system disorders
Anaphylactic reaction
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Immune system disorders
Food allergy
|
0.68%
1/147 • Number of events 2 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Immune system disorders
Hypersensitivity
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.66%
1/151 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Immune system disorders
Multiple allergies
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Immune system disorders
Seasonal allergy
|
2.7%
4/147 • Number of events 4 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 2 • 49 weeks
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Abscess neck
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Acarodermatitis
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Anal abscess
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Anal chlamydia infection
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Anal infection
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Anal tinea
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Bacteriuria
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Body tinea
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Breast abscess
|
0.00%
0/147 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Bronchitis
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
2.0%
3/148 • Number of events 4 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Cellulitis
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Cellulitis of male external genital organ
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Cellulitis staphylococcal
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Chikungunya virus infection
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Chlamydial infection
|
2.7%
4/147 • Number of events 4 • 49 weeks
|
2.6%
4/151 • Number of events 6 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
3.4%
5/148 • Number of events 5 • 49 weeks
|
|
Infections and infestations
Cytomegalovirus infection
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Dermatophytosis
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Diarrhoea infectious
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Ear infection
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Endometritis
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Epididymitis
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
1.4%
2/148 • Number of events 3 • 49 weeks
|
|
Infections and infestations
Escherichia infection
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Eye infection
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Folliculitis
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Fungal skin infection
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Gastroenteritis
|
2.0%
3/147 • Number of events 3 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
|
Infections and infestations
Gastroenteritis viral
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
4.0%
6/151 • Number of events 6 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
2.7%
4/148 • Number of events 4 • 49 weeks
|
|
Infections and infestations
Gastrointestinal infection
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Gastrointestinal viral infection
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 2 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Genital herpes
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
1.4%
2/148 • Number of events 5 • 49 weeks
|
|
Infections and infestations
Genitourinary tract gonococcal infection
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Gonorrhoea
|
2.0%
3/147 • Number of events 3 • 49 weeks
|
2.6%
4/151 • Number of events 4 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
|
Infections and infestations
Herpes simplex
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Infected bite
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Infected skin ulcer
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Influenza
|
2.0%
3/147 • Number of events 3 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Lyme disease
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Mastitis
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Nasopharyngitis
|
0.68%
1/147 • Number of events 2 • 49 weeks
|
2.0%
3/151 • Number of events 4 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
3.4%
5/148 • Number of events 5 • 49 weeks
|
|
Infections and infestations
Oesophageal candidiasis
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Onychomycosis
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Oral herpes
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
0.68%
1/148 • Number of events 3 • 49 weeks
|
|
Infections and infestations
Oral pustule
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Oropharyngeal gonococcal infection
|
2.7%
4/147 • Number of events 4 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
|
Infections and infestations
Otitis media
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Otitis media bacterial
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Papilloma viral infection
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Paronychia
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Pharyngeal chlamydia infection
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Pharyngitis
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Pharyngitis bacterial
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Pharyngitis streptococcal
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
3.3%
5/151 • Number of events 5 • 49 weeks
|
4.1%
6/148 • Number of events 6 • 49 weeks
|
1.4%
2/148 • Number of events 3 • 49 weeks
|
|
Infections and infestations
Pneumonia
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Primary syphilis
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Proctitis bacterial
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Proctitis chlamydial
|
6.8%
10/147 • Number of events 11 • 49 weeks
|
1.3%
2/151 • Number of events 3 • 49 weeks
|
2.0%
3/148 • Number of events 4 • 49 weeks
|
3.4%
5/148 • Number of events 5 • 49 weeks
|
|
Infections and infestations
Proctitis gonococcal
|
2.7%
4/147 • Number of events 4 • 49 weeks
|
3.3%
5/151 • Number of events 5 • 49 weeks
|
3.4%
5/148 • Number of events 5 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
|
Infections and infestations
Proctitis herpes
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Rash pustular
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 2 • 49 weeks
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Secondary syphilis
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Sinusitis
|
3.4%
5/147 • Number of events 6 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Sinusitis bacterial
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Skin infection
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Subcutaneous abscess
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Syphilis
|
2.0%
3/147 • Number of events 3 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
3.4%
5/148 • Number of events 5 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
|
Infections and infestations
Tinea cruris
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Tinea pedis
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Tonsillitis
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Tooth infection
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Upper respiratory tract infection
|
2.0%
3/147 • Number of events 3 • 49 weeks
|
6.0%
9/151 • Number of events 10 • 49 weeks
|
4.1%
6/148 • Number of events 7 • 49 weeks
|
6.1%
9/148 • Number of events 9 • 49 weeks
|
|
Infections and infestations
Urethritis
|
0.00%
0/147 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Infections and infestations
Urethritis chlamydial
|
0.68%
1/147 • Number of events 2 • 49 weeks
|
4.0%
6/151 • Number of events 8 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
|
Infections and infestations
Urethritis gonococcal
|
0.00%
0/147 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Urinary tract infection
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
3.3%
5/151 • Number of events 6 • 49 weeks
|
4.1%
6/148 • Number of events 8 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Viral infection
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
2.0%
3/151 • Number of events 3 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
|
Infections and infestations
Viral pharyngitis
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Viral upper respiratory tract infection
|
5.4%
8/147 • Number of events 8 • 49 weeks
|
7.3%
11/151 • Number of events 12 • 49 weeks
|
4.1%
6/148 • Number of events 6 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/147 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Infections and infestations
Wound infection
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Bone contusion
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Injury, poisoning and procedural complications
Burns second degree
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.00%
0/147 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
0.68%
1/147 • Number of events 2 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Injury, poisoning and procedural complications
Eye contusion
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Injury, poisoning and procedural complications
Eye injury
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Face injury
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Fracture
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Injury, poisoning and procedural complications
Human bite
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Injury, poisoning and procedural complications
Injury
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Joint injury
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Laceration
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
2.7%
4/148 • Number of events 4 • 49 weeks
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Limb injury
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Lip injury
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Injury, poisoning and procedural complications
Neck injury
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Injury, poisoning and procedural complications
Overdose
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Post procedural contusion
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Injury, poisoning and procedural complications
Post-traumatic neck syndrome
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Procedural headache
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Procedural pain
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
0.00%
0/147 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
|
Injury, poisoning and procedural complications
Tendon injury
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Traumatic iritis
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Injury, poisoning and procedural complications
Ulna fracture
|
0.68%
1/147 • Number of events 2 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Upper limb fracture
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Investigations
Alanine aminotransferase increased
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
5.3%
8/151 • Number of events 10 • 49 weeks
|
3.4%
5/148 • Number of events 6 • 49 weeks
|
1.4%
2/148 • Number of events 3 • 49 weeks
|
|
Investigations
Aspartate aminotransferase increased
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
4.6%
7/151 • Number of events 8 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
2.7%
4/148 • Number of events 5 • 49 weeks
|
|
Investigations
Blood albumin decreased
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Investigations
Blood bicarbonate decreased
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Investigations
Blood bilirubin increased
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
2.0%
3/151 • Number of events 3 • 49 weeks
|
1.4%
2/148 • Number of events 3 • 49 weeks
|
3.4%
5/148 • Number of events 8 • 49 weeks
|
|
Investigations
Blood cholesterol increased
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
2.0%
3/151 • Number of events 3 • 49 weeks
|
4.1%
6/148 • Number of events 6 • 49 weeks
|
4.1%
6/148 • Number of events 6 • 49 weeks
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Investigations
Blood creatinine increased
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
|
Investigations
Blood glucose decreased
|
2.0%
3/147 • Number of events 3 • 49 weeks
|
1.3%
2/151 • Number of events 3 • 49 weeks
|
5.4%
8/148 • Number of events 9 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
|
Investigations
Blood glucose increased
|
2.0%
3/147 • Number of events 6 • 49 weeks
|
3.3%
5/151 • Number of events 9 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
4.7%
7/148 • Number of events 10 • 49 weeks
|
|
Investigations
Blood phosphorus decreased
|
6.1%
9/147 • Number of events 13 • 49 weeks
|
8.6%
13/151 • Number of events 13 • 49 weeks
|
7.4%
11/148 • Number of events 13 • 49 weeks
|
8.1%
12/148 • Number of events 17 • 49 weeks
|
|
Investigations
Blood phosphorus increased
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Investigations
Blood potassium increased
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Investigations
Blood pressure decreased
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Investigations
Blood pressure diastolic increased
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Investigations
Blood pressure increased
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
1.4%
2/148 • Number of events 3 • 49 weeks
|
|
Investigations
Blood pressure systolic increased
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Investigations
Blood triglycerides increased
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Investigations
Carbon dioxide decreased
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Investigations
Creatinine urine increased
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Investigations
Haemoglobin decreased
|
1.4%
2/147 • Number of events 3 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
2.0%
3/148 • Number of events 4 • 49 weeks
|
|
Investigations
Lipids increased
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Investigations
Low density lipoprotein increased
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
2.6%
4/151 • Number of events 5 • 49 weeks
|
4.1%
6/148 • Number of events 7 • 49 weeks
|
4.1%
6/148 • Number of events 6 • 49 weeks
|
|
Investigations
Lymphocyte count decreased
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Investigations
Neutrophil count decreased
|
1.4%
2/147 • Number of events 4 • 49 weeks
|
2.6%
4/151 • Number of events 6 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Investigations
Protein urine present
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Metabolism and nutrition disorders
Abnormal loss of weight
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
2.7%
4/148 • Number of events 5 • 49 weeks
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Metabolism and nutrition disorders
Dehydration
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/147 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
1.4%
2/148 • Number of events 3 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Metabolism and nutrition disorders
Hyperlipidaemia
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
1.4%
2/148 • Number of events 4 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.0%
3/147 • Number of events 3 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
2.7%
4/148 • Number of events 7 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
2.0%
3/147 • Number of events 3 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.2%
12/147 • Number of events 21 • 49 weeks
|
9.9%
15/151 • Number of events 23 • 49 weeks
|
8.8%
13/148 • Number of events 19 • 49 weeks
|
4.7%
7/148 • Number of events 10 • 49 weeks
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
3/147 • Number of events 4 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.4%
5/147 • Number of events 6 • 49 weeks
|
2.6%
4/151 • Number of events 4 • 49 weeks
|
3.4%
5/148 • Number of events 5 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc degeneration
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.68%
1/147 • Number of events 2 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/147 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.7%
4/147 • Number of events 4 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
1.4%
2/148 • Number of events 3 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Pain in jaw
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acrochordon
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anogenital warts
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Skin papilloma
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Uterine leiomyoma
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Nervous system disorders
Amnesia
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Nervous system disorders
Carpal tunnel syndrome
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Nervous system disorders
Coordination abnormal
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Nervous system disorders
Diabetic neuropathy
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Nervous system disorders
Disturbance in attention
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Nervous system disorders
Dizziness
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Nervous system disorders
Dysarthria
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Nervous system disorders
Facial paralysis
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Nervous system disorders
Headache
|
5.4%
8/147 • Number of events 9 • 49 weeks
|
5.3%
8/151 • Number of events 8 • 49 weeks
|
4.1%
6/148 • Number of events 7 • 49 weeks
|
4.1%
6/148 • Number of events 7 • 49 weeks
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Nervous system disorders
Lethargy
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Nervous system disorders
Migraine
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Nervous system disorders
Motor dysfunction
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Nervous system disorders
Post-traumatic headache
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Nervous system disorders
Presyncope
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Nervous system disorders
Syncope
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
2.7%
4/148 • Number of events 4 • 49 weeks
|
|
Nervous system disorders
Tremor
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Psychiatric disorders
Abnormal dreams
|
0.00%
0/147 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Psychiatric disorders
Alcohol withdrawal syndrome
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Psychiatric disorders
Anxiety
|
3.4%
5/147 • Number of events 9 • 49 weeks
|
4.0%
6/151 • Number of events 6 • 49 weeks
|
3.4%
5/148 • Number of events 6 • 49 weeks
|
1.4%
2/148 • Number of events 3 • 49 weeks
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Psychiatric disorders
Depression
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
2.0%
3/151 • Number of events 5 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Psychiatric disorders
Drug abuse
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Psychiatric disorders
Hallucination, auditory
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Psychiatric disorders
Insomnia
|
2.0%
3/147 • Number of events 3 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
2.7%
4/148 • Number of events 4 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Psychiatric disorders
Intentional self-injury
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Psychiatric disorders
Libido decreased
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Psychiatric disorders
Mental disorder
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Psychiatric disorders
Mood swings
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Psychiatric disorders
Panic attack
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Psychiatric disorders
Stress
|
0.00%
0/147 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Psychiatric disorders
Substance abuse
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Psychiatric disorders
Thinking abnormal
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Psychiatric disorders
Tobacco withdrawal symptoms
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Renal and urinary disorders
Haematuria
|
2.0%
3/147 • Number of events 3 • 49 weeks
|
2.0%
3/151 • Number of events 3 • 49 weeks
|
1.4%
2/148 • Number of events 3 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
|
Renal and urinary disorders
Nocturia
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Renal and urinary disorders
Pollakiuria
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Renal and urinary disorders
Proteinuria
|
5.4%
8/147 • Number of events 9 • 49 weeks
|
2.0%
3/151 • Number of events 3 • 49 weeks
|
2.7%
4/148 • Number of events 4 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Renal and urinary disorders
Urethral discharge
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Reproductive system and breast disorders
Genital lesion
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Reproductive system and breast disorders
Haematospermia
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Reproductive system and breast disorders
Penile discharge
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Reproductive system and breast disorders
Penile pain
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Reproductive system and breast disorders
Prostatitis
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Reproductive system and breast disorders
Pruritus genital
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Reproductive system and breast disorders
Vaginal discharge
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Reproductive system and breast disorders
Vulvovaginal dryness
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
2.0%
3/148 • Number of events 3 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.0%
3/147 • Number of events 3 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Hypoventilation
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
2.7%
4/148 • Number of events 4 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.0%
3/147 • Number of events 3 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal inflammation
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Acne cystic
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Dandruff
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/147 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/147 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.68%
1/147 • Number of events 1 • 49 weeks
|
0.66%
1/151 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
|
Vascular disorders
Hyperaemia
|
0.00%
0/147 • 49 weeks
|
0.00%
0/151 • 49 weeks
|
0.68%
1/148 • Number of events 1 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
|
Vascular disorders
Hypertension
|
1.4%
2/147 • Number of events 2 • 49 weeks
|
1.3%
2/151 • Number of events 2 • 49 weeks
|
1.4%
2/148 • Number of events 2 • 49 weeks
|
0.00%
0/148 • 49 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee All study abstracts and publications are subject to HPTN Publication and Public Information Policies and Clinical Trial Agreements between NIAID (DAIDS) and company collaborators. The publication or other disclosure can be delayed for up to thirty additional business days for manuscripts \& five business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER