Trial Outcomes & Findings for Rollover Study of VX-770 in Cystic Fibrosis Subjects (NCT NCT01117012)
NCT ID: NCT01117012
Last Updated: 2015-07-07
Results Overview
Adverse Event: any untoward medical occurrence in a participant during the study, including any unfavorable and unintended sign, symptom, or disease whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that increased in severity or frequency after obtaining informed consent and assent (where applicable). SAE: medical event or condition, which resulted in any of following, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event. Non-Serious AEs included all AEs except SAEs.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
192 participants
Primary outcome timeframe
Study 105: Day 1 up to Week 168
Results posted on
2015-07-07
Participant Flow
Participants with Cystic Fibrosis (CF) who had completed the Study VX08-770-102 (Study 102/NCT00909532) and Study VX08-770-103 (Study 103/NCT00909727), were enrolled in this Study VX08-770-105 (Study 105/NCT01117012).
A total of 192 subjects were enrolled. Efficacy results are presented as per the treatment received in previous study (Placebo/Ivacaftor \[VX-770\]).
Participant milestones
| Measure |
Placebo/VX-770
Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 milligram (mg) tablet orally twice daily (q12h).
|
VX-770/VX-770
Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
103
|
|
Overall Study
COMPLETED
|
81
|
98
|
|
Overall Study
NOT COMPLETED
|
8
|
5
|
Reasons for withdrawal
| Measure |
Placebo/VX-770
Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 milligram (mg) tablet orally twice daily (q12h).
|
VX-770/VX-770
Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
|
|---|---|---|
|
Overall Study
Adverse Event
|
0
|
1
|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Undefined
|
4
|
3
|
Baseline Characteristics
Rollover Study of VX-770 in Cystic Fibrosis Subjects
Baseline characteristics by cohort
| Measure |
Placebo/VX-770
n=89 Participants
Participants who received placebo during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
|
VX-770/VX-770
n=103 Participants
Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
|
Total
n=192 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
22.0 years
STANDARD_DEVIATION 10.94 • n=5 Participants
|
23.2 years
STANDARD_DEVIATION 11.55 • n=7 Participants
|
22.6 years
STANDARD_DEVIATION 11.26 • n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
102 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
90 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study 105: Day 1 up to Week 168Population: Safety Set included all participants who received at least 1 dose of study drug during Study 105.
Adverse Event: any untoward medical occurrence in a participant during the study, including any unfavorable and unintended sign, symptom, or disease whether or not it was considered to be study drug related. This included any newly occurring event or previous condition that increased in severity or frequency after obtaining informed consent and assent (where applicable). SAE: medical event or condition, which resulted in any of following, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolonged hospitalization, persistent/significant disability/incapacity, congenital anomaly/birth defect, important medical event. Non-Serious AEs included all AEs except SAEs.
Outcome measures
| Measure |
VX-770
n=192 Participants
All participants who received VX-770 150 mg tablet orally q12h in Study 105.
|
VX-770/VX-770
Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
|
|---|---|---|
|
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
Non-Serious AEs
|
190 participants
|
—
|
|
Number of Participants With Non-Serious Adverse Events (AEs) and Serious Adverse Events (SAEs)
SAEs
|
70 participants
|
—
|
SECONDARY outcome
Timeframe: Study 105: Baseline through Week 96Population: Full Analysis Set.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as Study 105 Day 15.
Outcome measures
| Measure |
VX-770
n=89 Participants
All participants who received VX-770 150 mg tablet orally q12h in Study 105.
|
VX-770/VX-770
n=103 Participants
Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
|
|---|---|---|
|
Annualized Rate of Decline From Study 105 Baseline in Percent Predicted Forced Expiratory Volume in 1 Second (FEV1) Through Week 96
|
-0.30 percent predicted of FEV1 per year
Interval -2.47 to 1.86
|
-1.23 percent predicted of FEV1 per year
Interval -2.1 to -0.35
|
SECONDARY outcome
Timeframe: Study 105: Baseline through Week 96Population: Full Analysis Set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable for specified categories for each arm, respectively.
FEV1 is the volume of air that can forcibly be blown out in one second, after full inspiration. Predicted FEV1 (for age, gender, and height) was calculated using the Knudson method. Baseline was defined as the most recent measurement prior to intake of the first dose of study drug in Study 105. Absolute Change at Week 48 and Week 96 are reported.
Outcome measures
| Measure |
VX-770
n=85 Participants
All participants who received VX-770 150 mg tablet orally q12h in Study 105.
|
VX-770/VX-770
n=99 Participants
Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
|
|---|---|---|
|
Absolute Change From Study 105 Baseline in Percent Predicted FEV1 Through Week 96
Absolute Change at Week 48 (n = 85, 99)
|
9.2585 percent predicted of FEV1
Standard Deviation 9.63822
|
-0.4422 percent predicted of FEV1
Standard Deviation 8.62332
|
|
Absolute Change From Study 105 Baseline in Percent Predicted FEV1 Through Week 96
Absolute Change at Week 96 (n = 76, 97)
|
9.8194 percent predicted of FEV1
Standard Deviation 11.22812
|
0.1581 percent predicted of FEV1
Standard Deviation 9.01629
|
SECONDARY outcome
Timeframe: Study 105: Baseline through Week 96Population: Full Analysis Set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable for specified categories for each arm, respectively.
The CFQ-R is a validated patient-reported outcome measuring health-related quality of life for subjects with cystic fibrosis. Respiratory domain assessed respiratory symptoms (for example, coughing, congestion, wheezing), score range: 0-100; higher scores indicating fewer symptoms and better health-related quality of life. Absolute Change at Week 48 and Week 96 are reported.
Outcome measures
| Measure |
VX-770
n=86 Participants
All participants who received VX-770 150 mg tablet orally q12h in Study 105.
|
VX-770/VX-770
n=99 Participants
Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
|
|---|---|---|
|
Absolute Change From Study 105 Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 96
Absolute Change at Week 48 (n = 86, 99)
|
7.43 units on a scale
Standard Deviation 16.600
|
-1.94 units on a scale
Standard Deviation 16.550
|
|
Absolute Change From Study 105 Baseline in Cystic Fibrosis Questionnaire-Revised (CFQ-R) Respiratory Domain Score Through Week 96
Absolute Change at Week 96 (n = 77, 97)
|
10.05 units on a scale
Standard Deviation 15.254
|
0.77 units on a scale
Standard Deviation 14.305
|
SECONDARY outcome
Timeframe: Study 105: Day 1 through Week 96Population: Full Analysis Set.
Annualized event rate was calculated by regression with negative binomial distribution.
Outcome measures
| Measure |
VX-770
n=89 Participants
All participants who received VX-770 150 mg tablet orally q12h in Study 105.
|
VX-770/VX-770
n=103 Participants
Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
|
|---|---|---|
|
Annualized Pulmonary Exacerbation Event Rate
|
0.463 events per year
|
0.658 events per year
|
SECONDARY outcome
Timeframe: Study 105: Day 1 through Week 96Population: Full Analysis Set.
Outcome measures
| Measure |
VX-770
n=89 Participants
All participants who received VX-770 150 mg tablet orally q12h in Study 105.
|
VX-770/VX-770
n=103 Participants
Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
|
|---|---|---|
|
Annualized Duration of Pulmonary Exacerbation Events
|
10.89 Days per year
Standard Deviation 20.124
|
17.27 Days per year
Standard Deviation 30.974
|
SECONDARY outcome
Timeframe: Study 105: Baseline through Week 96Population: Full Analysis Set. Here, number of participants analyzed signifies participants who were evaluable for this outcome measure and n signifies participants who were evaluable for specified categories for each arm, respectively.
Weight is a measurement of nutritional status. Absolute change in weight, measured in kilograms (kg), at Week 48 and Week 96 are reported.
Outcome measures
| Measure |
VX-770
n=86 Participants
All participants who received VX-770 150 mg tablet orally q12h in Study 105.
|
VX-770/VX-770
n=99 Participants
Participants who received VX-770 during the parent study (Study 102 or 103), received VX-770 150 mg tablet orally q12h.
|
|---|---|---|
|
Absolute Change From Study 105 Baseline in Weight Through Week 96
Absolute Change at Week 48 (n = 86, 99)
|
4.03 kg
Standard Deviation 3.677
|
1.26 kg
Standard Deviation 3.844
|
|
Absolute Change From Study 105 Baseline in Weight Through Week 96
Absolute Change at Week 96 (n = 76, 97)
|
4.93 kg
Standard Deviation 5.577
|
2.62 kg
Standard Deviation 5.909
|
Adverse Events
VX-770
Serious events: 70 serious events
Other events: 190 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
VX-770
n=192 participants at risk
All participants who received VX-770 150 mg tablet orally q12h in Study 105.
|
|---|---|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
21.9%
42/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Influenza
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Appendicitis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Aspergilloma
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Bronchitis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Herpes zoster
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Lobar pneumonia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Lung abscess
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Lung infection pseudomonal
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Pneumonia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Pseudomonal bacteraemia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Respiratory tract infection viral
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Sepsis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Septic shock
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Distal intestinal obstruction syndrome
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Abdominal pain
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Constipation
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Anal fissure
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Distal ileal obstruction syndrome
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Gastritis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Haematemesis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Pancreatitis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Vomiting
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
3.6%
7/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Bullous lung disease
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Lower limb fracture
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Chest X-ray abnormal
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Haemoglobin decreased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Hepatic enzyme increased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Pulmonary function test decreased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Headache
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Hemiplegic migraine
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Hypoglycaemic seizure
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Migraine
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Psychiatric disorders
Affective disorder
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Psychiatric disorders
Depression
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Psychiatric disorders
Depression suicidal
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Psychiatric disorders
Major depression
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Psychiatric disorders
Suicidal ideation
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Ear and labyrinth disorders
Vestibular disorder
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Device occlusion
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Immune system disorders
Drug hypersensitivity
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Renal and urinary disorders
Renal tubular disorder
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
Other adverse events
| Measure |
VX-770
n=192 participants at risk
All participants who received VX-770 150 mg tablet orally q12h in Study 105.
|
|---|---|
|
Injury, poisoning and procedural complications
Laceration
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Contusion
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Excoriation
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Rash generalised
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Skin wrinkling
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Petechiae
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Infective pulmonary exacerbation of cystic fibrosis
|
49.0%
94/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Upper respiratory tract infection
|
33.9%
65/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Nasopharyngitis
|
20.3%
39/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Sinusitis
|
15.1%
29/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Gastroenteritis
|
6.8%
13/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Rhinitis
|
5.2%
10/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Influenza
|
4.7%
9/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Urinary tract infection
|
4.7%
9/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Respiratory tract infection viral
|
4.2%
8/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Tonsillitis
|
4.2%
8/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Oral candidiasis
|
3.6%
7/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Respiratory tract infection
|
3.6%
7/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Bronchitis
|
3.1%
6/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Candidiasis
|
3.1%
6/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Gastroenteritis viral
|
3.1%
6/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Viral upper respiratory tract infection
|
3.1%
6/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Oral herpes
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Pharyngitis
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Bacterial disease carrier
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Photosensitivity reaction
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Bronchopulmonary aspergillosis allergic
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Ear infection
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Pneumonia
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Acute sinusitis
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Cellulitis
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Cystitis
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Otitis media
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Pseudomonas infection
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Tooth abscess
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Viral infection
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Conjunctivitis infective
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Folliculitis
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Herpes zoster
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Laryngitis
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Lower respiratory tract infection
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Oropharyngeal candidiasis
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Otitis externa
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Tracheobronchitis
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Vulvovaginal candidiasis
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Alveolar osteitis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Bacteraemia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Body tinea
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Diverticulitis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Erythema migrans
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Fungal skin infection
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Furuncle
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Gastritis viral
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Genital candidiasis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Genital herpes
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Genital infection fungal
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Herpes simplex
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Herpes simplex ophthalmic
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Infection parasitic
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Labyrinthitis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Mycobacterial infection
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Nail bed infection bacterial
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Oesophageal candidiasis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Onychomycosis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Pneumonia staphylococcal
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Rhinotracheitis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Serratia infection
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Vaginitis bacterial
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Varicella
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Infections and infestations
Wound infection staphylococcal
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
44.8%
86/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
20.3%
39/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
13.5%
26/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
12.5%
24/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
12.5%
24/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Rales
|
9.9%
19/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Sputum increased
|
8.9%
17/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
8.3%
16/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
7.3%
14/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
7.3%
14/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
5.2%
10/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.7%
9/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Pleuritic pain
|
4.7%
9/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
4.7%
9/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Respiration abnormal
|
4.2%
8/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Nasal polyps
|
3.1%
6/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus hypersecretion
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Rhinitis allergic
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discharge discolouration
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal erythema
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Rhonchi
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Nasal inflammation
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Increased viscosity of bronchial secretion
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Nasal oedema
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Nasal turbinate abnormality
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Sputum discoloured
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Throat irritation
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Allergic cough
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial obstruction
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Rash follicular
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Nasal discomfort
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus mucosal hypertrophy
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngeal oedema
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Pleurisy
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Prolonged expiration
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Sneezing
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar inflammation
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Abdominal pain
|
12.0%
23/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Constipation
|
11.5%
22/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Diarrhoea
|
10.9%
21/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Vomiting
|
10.9%
21/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Abdominal pain upper
|
9.9%
19/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Nausea
|
9.9%
19/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Dyspepsia
|
4.7%
9/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
4.7%
9/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Flatulence
|
3.1%
6/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Toothache
|
3.1%
6/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Abdominal distension
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Distal ileal obstruction syndrome
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Abdominal discomfort
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Haemorrhoids
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Steatorrhoea
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Duodenitis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Gastric hypomotility
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Gastritis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Gastrointestinal hypomotility
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Gingival pain
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Inguinal hernia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Lip dry
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Lip swelling
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Mouth ulceration
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Tooth impacted
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Bacterial test positive
|
8.3%
16/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Weight decreased
|
6.8%
13/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Aspartate aminotransferase increased
|
4.7%
9/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Pulmonary function test decreased
|
4.2%
8/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Alanine aminotransferase increased
|
3.1%
6/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Fungal test positive
|
3.1%
6/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Glucose urine present
|
3.1%
6/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Vitamin D decreased
|
3.1%
6/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Blood glucose increased
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Prothrombin time prolonged
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Gamma-glutamyltransferase increased
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Hepatic enzyme increased
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Liver function test abnormal
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Blood bilirubin increased
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Blood creatinine increased
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Culture throat positive
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Forced expiratory volume decreased
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Skin fissures
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Skin odour abnormal
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
White blood cell count increased
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Blood alkaline phosphatase increased
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Blood glucose decreased
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Blood iron decreased
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Blood urine present
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Body temperature increased
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Breath sounds abnormal
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Cardiac murmur
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Electrocardiogram QT prolonged
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Eosinophil count increased
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Neutrophil count increased
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Platelet count increased
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Protein urine present
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Spirometry abnormal
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Activated partial thromboplastin time prolonged
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Blood albumin increased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Blood bilirubin unconjugated increased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Blood calcium increased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Blood cortisol increased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Blood immunoglobulin E increased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Blood pressure increased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Blood urea increased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Clostridium test positive
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Coagulation factor increased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Electrocardiogram T wave peaked
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Gastrointestinal examination abnormal
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Glycosylated haemoglobin increased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Haemoglobin increased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Monocyte count increased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Nitrite urine present
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Peak expiratory flow rate decreased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Serum ferritin decreased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Sputum abnormal
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Urine leukocyte esterase
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Urine leukocyte esterase positive
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Investigations
Weight increased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Headache
|
23.4%
45/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Dizziness
|
6.2%
12/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Sinus headache
|
3.6%
7/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Hypoaesthesia
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Lethargy
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Paraesthesia
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Migraine
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Convulsion
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Syncope
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Ageusia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Burning sensation
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Epilepsy
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Nervous system disorders
Memory impairment
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Pyrexia
|
18.2%
35/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Fatigue
|
6.8%
13/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Catheter site pain
|
3.6%
7/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Chest pain
|
3.1%
6/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Influenza like illness
|
3.1%
6/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Non-cardiac chest pain
|
3.1%
6/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Pain
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Chills
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Malaise
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Oedema peripheral
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Asthenia
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Chest discomfort
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Injection site pain
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Adverse drug reaction
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Catheter site swelling
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Drug interaction
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Exercise tolerance decreased
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Infusion site pain
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
General disorders
Medical device pain
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
13.5%
26/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.3%
14/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
3.6%
7/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
3.6%
7/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Arthropathy
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Fibromyalgia
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Clubbing
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Costochondritis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal stiffness
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Osteopenia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Periarthritis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Tendon pain
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Rash
|
6.8%
13/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Acne
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Sunburn
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Drug eruption
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Skin and subcutaneous tissue disorders
Erythema
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Procedural pain
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Hand fracture
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Meniscus lesion
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Skeletal injury
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Corneal abrasion
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Foreign body in eye
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Incision site pain
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Muscle injury
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Muscle rupture
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Post procedural complication
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Post-traumatic pain
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Radius fracture
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Scratch
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Stab wound
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Sternal injury
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Tendon rupture
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Injury, poisoning and procedural complications
Tongue injury
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Glucose tolerance impaired
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Iron deficiency
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Vitamin K deficiency
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Dehydration
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Hypovitaminosis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Increased appetite
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Insulin resistance
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Lactose intolerance
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Vitamin A deficiency
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Metabolism and nutrition disorders
Zinc deficiency
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Psychiatric disorders
Anxiety
|
5.7%
11/192 • Study 105: Day 1 through Week 168
|
|
Psychiatric disorders
Depression
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Psychiatric disorders
Insomnia
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Psychiatric disorders
Sleep disorder
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Psychiatric disorders
Abnormal dreams
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Psychiatric disorders
Adjustment disorder
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Psychiatric disorders
Attention deficit/hyperactivity disorder
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Psychiatric disorders
Mood swings
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Psychiatric disorders
Phagophobia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Ear and labyrinth disorders
Ear pain
|
3.1%
6/192 • Study 105: Day 1 through Week 168
|
|
Ear and labyrinth disorders
Vertigo
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Ear and labyrinth disorders
Cerumen impaction
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Ear and labyrinth disorders
Deafness
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Ear and labyrinth disorders
Ear discomfort
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Ear and labyrinth disorders
Ear pruritus
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Ear and labyrinth disorders
Middle ear inflammation
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Ear and labyrinth disorders
Tinnitus
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Ear and labyrinth disorders
Tympanic membrane hyperaemia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Eye disorders
Conjunctivitis
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
Eye disorders
Vision blurred
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Eye disorders
Conjunctivitis allergic
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Eye disorders
Dry eye
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Eye disorders
Eye pruritus
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Eye disorders
Lens disorder
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Eye disorders
Meibomian gland dysfunction
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Eye disorders
Myopia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Eye disorders
Ocular vascular disorder
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Eye disorders
Visual acuity reduced
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Eye disorders
Visual impairment
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Eye disorders
Vitreous floaters
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Immune system disorders
Seasonal allergy
|
4.7%
9/192 • Study 105: Day 1 through Week 168
|
|
Immune system disorders
Drug hypersensitivity
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Immune system disorders
Hypersensitivity
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Immune system disorders
Allergy to animal
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
3.1%
6/192 • Study 105: Day 1 through Week 168
|
|
Reproductive system and breast disorders
Breast mass
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Reproductive system and breast disorders
Cervix inflammation
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Reproductive system and breast disorders
Dyspareunia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Reproductive system and breast disorders
Menstruation irregular
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Reproductive system and breast disorders
Metrorrhagia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Reproductive system and breast disorders
Ovarian cyst
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Reproductive system and breast disorders
Pelvic pain
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Renal and urinary disorders
Haematuria
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Renal and urinary disorders
Nephrolithiasis
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Renal and urinary disorders
Polyuria
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Renal and urinary disorders
Cystitis interstitial
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Renal and urinary disorders
Glycosuria
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Renal and urinary disorders
Proteinuria
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Renal and urinary disorders
Renal colic
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Renal and urinary disorders
Renal cyst
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
2.6%
5/192 • Study 105: Day 1 through Week 168
|
|
Blood and lymphatic system disorders
Coagulopathy
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Blood and lymphatic system disorders
Neutrophilia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Blood and lymphatic system disorders
Polycythaemia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Cardiac disorders
Palpitations
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Cardiac disorders
Tachycardia
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Cardiac disorders
Angina pectoris
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Cardiac disorders
Intracardiac thrombus
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Vascular disorders
Hypertension
|
1.6%
3/192 • Study 105: Day 1 through Week 168
|
|
Vascular disorders
Flushing
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Vascular disorders
Haematoma
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Congenital, familial and genetic disorders
Cystic fibrosis related diabetes
|
2.1%
4/192 • Study 105: Day 1 through Week 168
|
|
Congenital, familial and genetic disorders
Cataract congenital
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Congenital, familial and genetic disorders
Cystic fibrosis pancreatic
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Endocrine disorders
Hypothyroidism
|
1.0%
2/192 • Study 105: Day 1 through Week 168
|
|
Endocrine disorders
Adrenal suppression
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Hepatobiliary disorders
Cholecystitis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Hepatobiliary disorders
Hyperbilirubinaemia
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Fibroadenoma of breast
|
0.52%
1/192 • Study 105: Day 1 through Week 168
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60