Trial Outcomes & Findings for A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study (NCT NCT00128830)
NCT ID: NCT00128830
Last Updated: 2013-06-20
Results Overview
Number of participants who reported at least 1 of the adverse events.
COMPLETED
PHASE2
211 participants
Up to 3 years
2013-06-20
Participant Flow
In this study, 211 participants were enrolled in 12 different countries. The majority of participants (49%) were enrolled in the United States.
In total, 211 participants (93 who rolled over from the etravirine arm of study TMC125-C203 (NCT00412646), 85 who rolled over from the etravirine arm of study TMC125-C223 (NCT00081978), 29 who rolled over from study TMC125-C211 (NCT00111280) and 4 who rolled over from study TMC125-C209) received treatment with etravirine.
Participant milestones
| Measure |
Etravirine
800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
|
|---|---|
|
Overall Study
STARTED
|
211
|
|
Overall Study
COMPLETED
|
139
|
|
Overall Study
NOT COMPLETED
|
72
|
Reasons for withdrawal
| Measure |
Etravirine
800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
|
|---|---|
|
Overall Study
Adverse Event
|
10
|
|
Overall Study
Withdrawal by Subject
|
14
|
|
Overall Study
Lost to Follow-up
|
4
|
|
Overall Study
Reached a virologic endpoint
|
29
|
|
Overall Study
Non-compliant
|
4
|
|
Overall Study
Discontinued or ineligible for study
|
2
|
|
Overall Study
Other
|
9
|
Baseline Characteristics
A Study With TMC125 in Human Immunodeficiency Virus (HIV) Type 1 Infected Patients, Who Were Treated With TMC125 Arm in a Sponsor-Selected TMC125 Study
Baseline characteristics by cohort
| Measure |
Etravirine
n=211 Participants
800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
|
|---|---|
|
Age Continuous
|
46.0 years
FULL_RANGE 7.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
190 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
24 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
164 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
16 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 3 yearsPopulation: Intent-to-treat population: Participants who received at least 1 dose of study medication were included
Number of participants who reported at least 1 of the adverse events.
Outcome measures
| Measure |
Viral Load More Than or Equal to 50 Copies/mL
n=211 Participants
Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
|
Viral Load Less Than 50 Copies/mL
Viral load less than 50 copies/mL at TMC125-C229 Baseline
|
|---|---|---|
|
Number of Participants With Adverse Events
|
195 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 48
Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 48. The last visit of the TMC125 feeder study (TMC125-C203 \[NCT00412646\], TMC125-C223 \[NCT00081978\], TMC125 C211 \[NCT00111280\] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.
Outcome measures
| Measure |
Viral Load More Than or Equal to 50 Copies/mL
n=80 Participants
Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
|
Viral Load Less Than 50 Copies/mL
n=93 Participants
Viral load less than 50 copies/mL at TMC125-C229 Baseline
|
|---|---|---|
|
Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 48
|
22 Participants
|
80 Participants
|
SECONDARY outcome
Timeframe: Week 96Population: Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96
Number of participants who had viral load more than or equal to 50 copies/mL and less than 50 copies/mL at TMC125-C229 baseline and who achieved virologic response (ie, viral load less than 50 copies/mL) at Week 96. The last visit of the TMC125 feeder study (TMC125-C203 \[NCT00412646\], TMC125-C223 \[NCT00081978\], TMC125 C211 \[NCT00111280\] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.
Outcome measures
| Measure |
Viral Load More Than or Equal to 50 Copies/mL
n=62 Participants
Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
|
Viral Load Less Than 50 Copies/mL
n=83 Participants
Viral load less than 50 copies/mL at TMC125-C229 Baseline
|
|---|---|---|
|
Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL) at Week 96
|
28 Participants
|
72 Participants
|
SECONDARY outcome
Timeframe: Week 96Population: Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96
Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 \[NCT00412646\], TMC125-C223 \[NCT00081978\], TMC125 C211 \[NCT00111280\] or TMC125-C209 feeder studies).
Outcome measures
| Measure |
Viral Load More Than or Equal to 50 Copies/mL
n=181 Participants
Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
|
Viral Load Less Than 50 Copies/mL
Viral load less than 50 copies/mL at TMC125-C229 Baseline
|
|---|---|---|
|
Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Less Than 400 Copies/mL; and Greater Than or Equal to 1 Log 10 Decrease From Baseline) at Week 96
Viral load (VL) less than 50 copies/mL
|
105 Participants
|
—
|
|
Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Less Than 400 Copies/mL; and Greater Than or Equal to 1 Log 10 Decrease From Baseline) at Week 96
Viral load less than 400 copies/mL
|
124 Participants
|
—
|
|
Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Less Than 400 Copies/mL; and Greater Than or Equal to 1 Log 10 Decrease From Baseline) at Week 96
Viral load more than or equal to 1log10
|
132 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 192Population: Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 192
Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 \[NCT00412646\], TMC125-C223 \[NCT00081978\], TMC125 C211 \[NCT00111280\] or TMC125-C209 feeder studies).
Outcome measures
| Measure |
Viral Load More Than or Equal to 50 Copies/mL
n=98 Participants
Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
|
Viral Load Less Than 50 Copies/mL
Viral load less than 50 copies/mL at TMC125-C229 Baseline
|
|---|---|---|
|
Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Viral Load Less Than 400 Copies/mL; and Greater Than or Equal to 1 log10 Decrease From Baseline) at Week 192
Viral load (VL) less than 50 copies/mL
|
69 Participants
|
—
|
|
Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Viral Load Less Than 400 Copies/mL; and Greater Than or Equal to 1 log10 Decrease From Baseline) at Week 192
VL less than 400 copies/mL
|
81 Participants
|
—
|
|
Number of Participants Who Achieved Virologic Response (ie, Viral Load Less Than 50 Copies/mL; Viral Load Less Than 400 Copies/mL; and Greater Than or Equal to 1 log10 Decrease From Baseline) at Week 192
VL greater than or equal to 1log10
|
83 Participants
|
—
|
SECONDARY outcome
Timeframe: Week 48Population: Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 48
The last visit of the TMC125 feeder study (TMC125-C203 \[NCT00412646\], TMC125-C223 \[NCT00081978\], TMC125 C211 \[NCT00111280\] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.
Outcome measures
| Measure |
Viral Load More Than or Equal to 50 Copies/mL
n=172 Participants
Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
|
Viral Load Less Than 50 Copies/mL
Viral load less than 50 copies/mL at TMC125-C229 Baseline
|
|---|---|---|
|
Median Change From TMC125-C229 Basline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 48
|
21.50 x 100000 cells/L
Interval -422.0 to 1119.0
|
—
|
SECONDARY outcome
Timeframe: Week 96Population: Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96
The last visit of the TMC125 feeder study (TMC125-C203 \[NCT00412646\], TMC125-C223 \[NCT00081978\], TMC125 C211 \[NCT00111280\] or TMC125-C209 feeder studies) was considered to be the TMC125-C229 baseline.
Outcome measures
| Measure |
Viral Load More Than or Equal to 50 Copies/mL
n=142 Participants
Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
|
Viral Load Less Than 50 Copies/mL
Viral load less than 50 copies/mL at TMC125-C229 Baseline
|
|---|---|---|
|
Median Change From TMC125-C229 Baseline in Cluster of Differentiation 4 (CD4+) Cell Count at Week 96
|
18.50 x 1000000 cells/L
Interval -460.0 to 391.0
|
—
|
SECONDARY outcome
Timeframe: Week 96Population: Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 96
Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 \[NCT00412646\], TMC125-C223 \[NCT00081978\], TMC125 C211 \[NCT00111280\] or TMC125-C209 feeder studies).
Outcome measures
| Measure |
Viral Load More Than or Equal to 50 Copies/mL
n=181 Participants
Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
|
Viral Load Less Than 50 Copies/mL
Viral load less than 50 copies/mL at TMC125-C229 Baseline
|
|---|---|---|
|
Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 96
|
120.00 x 1000000 cells/mL
Interval -393.0 to 1590.0
|
—
|
SECONDARY outcome
Timeframe: Week 192Population: Intent-to-treat participants who received at least one dose of study medication with evaluable data at Week 192
Baseline considered for this outcome is the baseline in the respective TMC125-C229 feeder study (TMC125-C203 \[NCT00412646\], TMC125-C223 \[NCT00081978\], TMC125 C211 \[NCT00111280\] or TMC125-C209 feeder studies).
Outcome measures
| Measure |
Viral Load More Than or Equal to 50 Copies/mL
n=96 Participants
Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
|
Viral Load Less Than 50 Copies/mL
Viral load less than 50 copies/mL at TMC125-C229 Baseline
|
|---|---|---|
|
Median Change in Cluster of Differentiation 4 (CD4+) Cell Count From Baseline in TMC125-C229 Feeder Study at Week 192
|
149.50 x 1000000 cells/mL
Interval -535.0 to 1847.0
|
—
|
SECONDARY outcome
Timeframe: Baseline and Endpoint (ie, the last available time point during the treatment period)Population: Intent-to-treat population: Participants who received at least 1 dose of study medication were included
Emerging mutations are the mutation which are not present at baseline (last visit of the TMC125 feeder study \[TMC125-C203 (NCT00412646), TMC125-C223 (NCT00081978), TMC125 C211 (NCT00111280) or TMC125-C209 feeder studies\]) and are present at endpoint (last available timepoint during treatment period for each individual participant).
Outcome measures
| Measure |
Viral Load More Than or Equal to 50 Copies/mL
n=211 Participants
Viral load more than or equal to 50 copies/mL at TMC125-C229 Baseline
|
Viral Load Less Than 50 Copies/mL
Viral load less than 50 copies/mL at TMC125-C229 Baseline
|
|---|---|---|
|
Number of Participants With Emerging Mutation (Reverse Transcriptase Mutation)
L100I
|
8 Participants
|
—
|
|
Number of Participants With Emerging Mutation (Reverse Transcriptase Mutation)
Y181C
|
7 Participants
|
—
|
|
Number of Participants With Emerging Mutation (Reverse Transcriptase Mutation)
A98G
|
6 Participants
|
—
|
|
Number of Participants With Emerging Mutation (Reverse Transcriptase Mutation)
V179I
|
6 Participants
|
—
|
|
Number of Participants With Emerging Mutation (Reverse Transcriptase Mutation)
K103N
|
5 Participants
|
—
|
|
Number of Participants With Emerging Mutation (Reverse Transcriptase Mutation)
H221Y
|
5 Participants
|
—
|
Adverse Events
Etravirine
Serious adverse events
| Measure |
Etravirine
n=211 participants at risk
800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.47%
1/211 • Up to 3 years
|
|
Cardiac disorders
Acute coronary syndrome
|
0.47%
1/211 • Up to 3 years
|
|
Cardiac disorders
Acute myocardial infarction
|
0.47%
1/211 • Up to 3 years
|
|
Cardiac disorders
Angina pectoris
|
0.47%
1/211 • Up to 3 years
|
|
Cardiac disorders
Angina unstable
|
0.47%
1/211 • Up to 3 years
|
|
Cardiac disorders
Arrhythmia
|
0.47%
1/211 • Up to 3 years
|
|
Cardiac disorders
Atrial flutter
|
0.47%
1/211 • Up to 3 years
|
|
Cardiac disorders
Cardiogenic shock
|
0.47%
1/211 • Up to 3 years
|
|
Cardiac disorders
Coronary artery disease
|
0.47%
1/211 • Up to 3 years
|
|
Cardiac disorders
Coronary artery occlusion
|
0.47%
1/211 • Up to 3 years
|
|
Cardiac disorders
Myocardial infarction
|
0.95%
2/211 • Up to 3 years
|
|
Cardiac disorders
Myocardial ischaemia
|
0.47%
1/211 • Up to 3 years
|
|
Congenital, familial and genetic disorders
Fanconi syndrome
|
0.47%
1/211 • Up to 3 years
|
|
Endocrine disorders
Adrenal insufficiency
|
0.95%
2/211 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal distension
|
0.47%
1/211 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhoea haemorrhagic
|
0.47%
1/211 • Up to 3 years
|
|
Gastrointestinal disorders
Gastritis
|
0.95%
2/211 • Up to 3 years
|
|
Gastrointestinal disorders
Pancreatitis
|
0.95%
2/211 • Up to 3 years
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.47%
1/211 • Up to 3 years
|
|
General disorders
Chest discomfort
|
0.47%
1/211 • Up to 3 years
|
|
General disorders
Chills
|
0.47%
1/211 • Up to 3 years
|
|
General disorders
Pyrexia
|
0.47%
1/211 • Up to 3 years
|
|
Hepatobiliary disorders
Cholecystitis
|
0.47%
1/211 • Up to 3 years
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Acute sinusitis
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Arthritis bacterial
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Arthritis infective
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Bacteraemia
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Bronchitis
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Cellulitis
|
1.4%
3/211 • Up to 3 years
|
|
Infections and infestations
Gastrointestinal infection
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Groin abscess
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Herpes simplex
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Histoplasmosis disseminated
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Meningitis aseptic
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Pneumocystis jiroveCI pneumonia
|
0.95%
2/211 • Up to 3 years
|
|
Infections and infestations
Pneumonia
|
2.4%
5/211 • Up to 3 years
|
|
Infections and infestations
Pneumonia viral
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Respiratory tract infection
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Secondary syphilis
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Sepsis
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Staphylococcal abscess
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Subcutaneous abscess
|
0.47%
1/211 • Up to 3 years
|
|
Infections and infestations
Urinary tract infection
|
0.47%
1/211 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.47%
1/211 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.47%
1/211 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Injury
|
0.47%
1/211 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.47%
1/211 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.47%
1/211 • Up to 3 years
|
|
Injury, poisoning and procedural complications
Traumatic brain injury
|
0.47%
1/211 • Up to 3 years
|
|
Investigations
Biopsy kidney
|
0.47%
1/211 • Up to 3 years
|
|
Investigations
Biopsy liver
|
0.47%
1/211 • Up to 3 years
|
|
Metabolism and nutrition disorders
Dehydration
|
0.95%
2/211 • Up to 3 years
|
|
Metabolism and nutrition disorders
Diabetes mellitus non-insulin-dependent
|
0.47%
1/211 • Up to 3 years
|
|
Metabolism and nutrition disorders
Metabolic acidosis
|
0.47%
1/211 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.47%
1/211 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.47%
1/211 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.47%
1/211 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.47%
1/211 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Anal cancer recurrent
|
0.47%
1/211 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.47%
1/211 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gum neoplasm malignant stage unspecified
|
0.47%
1/211 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm
|
0.47%
1/211 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.47%
1/211 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hodgkin's disease
|
0.47%
1/211 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kaposi's sarcoma
|
0.47%
1/211 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.47%
1/211 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to peritoneum
|
0.47%
1/211 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.47%
1/211 • Up to 3 years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.47%
1/211 • Up to 3 years
|
|
Nervous system disorders
Chronic inflammatory demyelinating polyradiculoneuropathy
|
0.47%
1/211 • Up to 3 years
|
|
Nervous system disorders
Headache
|
0.47%
1/211 • Up to 3 years
|
|
Renal and urinary disorders
Renal artery occlusion
|
0.47%
1/211 • Up to 3 years
|
|
Renal and urinary disorders
Renal failure acute
|
0.95%
2/211 • Up to 3 years
|
|
Renal and urinary disorders
Renal impairment
|
0.47%
1/211 • Up to 3 years
|
|
Reproductive system and breast disorders
Prostatitis
|
0.47%
1/211 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.47%
1/211 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary artery thrombosis
|
0.47%
1/211 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Decubitus ulcer
|
0.47%
1/211 • Up to 3 years
|
|
Surgical and medical procedures
Abdominoplasty
|
0.47%
1/211 • Up to 3 years
|
|
Surgical and medical procedures
Hospitalisation
|
0.47%
1/211 • Up to 3 years
|
|
Surgical and medical procedures
Wound treatment
|
0.47%
1/211 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
0.47%
1/211 • Up to 3 years
|
Other adverse events
| Measure |
Etravirine
n=211 participants at risk
800 mg twice daily (formulation TF035), and after formulation switch, 200 mg twice daily (formulation F060)
|
|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
10.4%
22/211 • Up to 3 years
|
|
Gastrointestinal disorders
Abdominal pain
|
7.6%
16/211 • Up to 3 years
|
|
Gastrointestinal disorders
Diarrhoea
|
17.5%
37/211 • Up to 3 years
|
|
Gastrointestinal disorders
Nausea
|
8.5%
18/211 • Up to 3 years
|
|
Gastrointestinal disorders
Vomiting
|
5.2%
11/211 • Up to 3 years
|
|
General disorders
Fatigue
|
10.9%
23/211 • Up to 3 years
|
|
General disorders
Injection site reaction
|
7.1%
15/211 • Up to 3 years
|
|
General disorders
Pyrexia
|
7.6%
16/211 • Up to 3 years
|
|
Infections and infestations
Bronchitis
|
7.1%
15/211 • Up to 3 years
|
|
Infections and infestations
Nasopharyngitis
|
10.9%
23/211 • Up to 3 years
|
|
Infections and infestations
Sinusitis
|
11.4%
24/211 • Up to 3 years
|
|
Infections and infestations
Upper respiratory tract infection
|
17.1%
36/211 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
10.9%
23/211 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.0%
19/211 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
12/211 • Up to 3 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
6.2%
13/211 • Up to 3 years
|
|
Nervous system disorders
Headache
|
9.5%
20/211 • Up to 3 years
|
|
Psychiatric disorders
Depression
|
5.2%
11/211 • Up to 3 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
9.5%
20/211 • Up to 3 years
|
|
Skin and subcutaneous tissue disorders
Rash
|
7.6%
16/211 • Up to 3 years
|
|
Vascular disorders
Hypertension
|
5.2%
11/211 • Up to 3 years
|
Additional Information
Trial Physician
Tibotec Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60