Trial Outcomes & Findings for A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer (NCT NCT00130728)
NCT ID: NCT00130728
Last Updated: 2021-01-14
Results Overview
Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
636 participants
Primary outcome timeframe
From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years)
Results posted on
2021-01-14
Participant Flow
Participant milestones
| Measure |
Erlotinib HCl + Bevacizumab
oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
|
Erlotinib HCl + Placebo
oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
|
|---|---|---|
|
Overall Study
STARTED
|
319
|
317
|
|
Overall Study
Received Study Drug (Safety Population)
|
313
|
313
|
|
Overall Study
COMPLETED
|
57
|
57
|
|
Overall Study
NOT COMPLETED
|
262
|
260
|
Reasons for withdrawal
| Measure |
Erlotinib HCl + Bevacizumab
oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
|
Erlotinib HCl + Placebo
oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
|
|---|---|---|
|
Overall Study
Death
|
258
|
258
|
|
Overall Study
Lost to Follow-up
|
4
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
2
|
Baseline Characteristics
A Study to Evaluate the Efficacy of Bevacizumab in Combination With Tarceva for Advanced Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Erlotinib HCl + Bevacizumab
n=319 Participants
oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
|
Erlotinib HCl + Placebo
n=317 Participants
oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
|
Total
n=636 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.8 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
65.0 years
STANDARD_DEVIATION 10.3 • n=7 Participants
|
64.9 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
|
Age, Customized
Between 18 and 59 years
|
91 Participants
n=5 Participants
|
90 Participants
n=7 Participants
|
181 Participants
n=5 Participants
|
|
Age, Customized
Between 60 and 64 years
|
62 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Age, Customized
Between 65 and 69 years
|
59 Participants
n=5 Participants
|
53 Participants
n=7 Participants
|
112 Participants
n=5 Participants
|
|
Age, Customized
>= 70 years
|
107 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
215 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
295 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
171 Participants
n=5 Participants
|
170 Participants
n=7 Participants
|
341 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From the date of randomization until the date of patient death from any cause, or the date of last contact. (Up to 3.1 years)Population: Randomized patients
Overall Survival was defined as the period from the date of randomization until the date of patient death from any cause. For patients who had not died, survival data was censored at the date of last contact.
Outcome measures
| Measure |
Erlotinib HCl + Bevacizumab
n=319 Participants
oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
|
Erlotinib HCl + Placebo
n=317 Participants
oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
|
|---|---|---|
|
Overall Survival (OS) Among All Randomized Patients
|
9.3 months
Interval 7.39 to 11.47
|
9.2 months
Interval 7.85 to 11.6
|
SECONDARY outcome
Timeframe: From randomization to documented disease progression or death on study treatment, whichever occurred first. (Up to 3.1 years)Population: Randomized patients
PFS was defined as the time from randomization to documented disease progression, as determined by the investigator using the Response Evaluation Criteria in Solid Tumors (RECIST), or death on study treatment, whichever occurred first.
Outcome measures
| Measure |
Erlotinib HCl + Bevacizumab
n=319 Participants
oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
|
Erlotinib HCl + Placebo
n=317 Participants
oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
|
|---|---|---|
|
Progression-free Survival (PFS)
|
3.4 months
Interval 2.79 to 4.27
|
1.7 months
Interval 1.48 to 2.53
|
SECONDARY outcome
Timeframe: The median duration of Objective response was up to 9.7 monthsPopulation: Only patients with measurable disease at baseline were included in the analysis of the objective response. Patients without a post-baseline tumor assessment were considered non-responder.
Objective response was defined as a complete or partial response determined by RECIST on two consecutive occasions \>= 4 weeks apart.
Outcome measures
| Measure |
Erlotinib HCl + Bevacizumab
n=301 Participants
oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
|
Erlotinib HCl + Placebo
n=306 Participants
oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
|
|---|---|---|
|
Percentage of Participants With Objective Response
|
12.6 Percentage of participants
Interval 9.1 to 16.8
|
6.2 Percentage of participants
Interval 3.8 to 9.5
|
SECONDARY outcome
Timeframe: Period from Objective response until disease progression or death on study treatment. (Up to 29.5 months)Population: Patients with an objective response
Duration of objective response was defined as the period from the date of the initial partial or complete response until the date of disease progression or death on study treatment from any cause. For patients who had not died, data was censored at the date of last contact.
Outcome measures
| Measure |
Erlotinib HCl + Bevacizumab
n=38 Participants
oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
|
Erlotinib HCl + Placebo
n=19 Participants
oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
|
|---|---|---|
|
Duration of Objective Response
|
9.7 months
Interval 6.9 to 19.48
|
8.4 months
Interval 3.48 to 14.88
|
Adverse Events
Erlotinib HCl + Bevacizumab
Serious events: 146 serious events
Other events: 310 other events
Deaths: 258 deaths
Erlotinib HCl + Placebo
Serious events: 121 serious events
Other events: 306 other events
Deaths: 258 deaths
Serious adverse events
| Measure |
Erlotinib HCl + Bevacizumab
n=313 participants at risk
oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
|
Erlotinib HCl + Placebo
n=313 participants at risk
oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Cardiac disorders
Acute Myocardial Infarction
|
1.3%
4/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Cardiac disorders
Angina Pectoris
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Cardiac disorders
Atrial Fibrillation
|
0.96%
3/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
1.3%
4/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Cardiac disorders
Atrial Flutter
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Cardiac disorders
Cardiac Arrest
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Cardiac disorders
Cardiac Failure Congestive
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Cardiac disorders
Cardiopulmonary Failure
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Cardiac disorders
Coronary Artery Disease
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Cardiac disorders
Coronary Artery Stenosis
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Cardiac disorders
Myocardial Infarction
|
1.6%
5/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Cardiac disorders
Pericardial Effusion
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Cardiac disorders
Pericarditis
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Eye disorders
Blindness Unilateral
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Eye disorders
Retinal Haemorrhage
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Eye disorders
Vision Blurred
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Abdominal Pain
|
1.9%
6/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Abdominal Pain Upper
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Constipation
|
0.96%
3/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Diarrhoea
|
2.2%
7/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
1.3%
4/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Diverticulum
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Duodenal Ulcer
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Duodenal Ulcer Haemorrhage
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Dysphagia
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Faecaloma
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Gastritis Erosive
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Gastrointestinal Haemorrhage
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Gastrointestinal Perforation
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Haemorrhoidal Haemorrhage
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Ileus
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Inguinal Hernia, Obstructive
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Intestinal Perforation
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Large Intestine Perforation
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Lower Gastrointestinal Haemorrhage
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Nausea
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Oesophageal Obstruction
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Oesophageal Perforation
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Oesophageal Stenosis
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Pancreatitis
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Pancreatitis Acute
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Peritonitis
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Rectal Haemorrhage
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Small Intestinal Obstruction
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Upper Gastrointestinal Haemorrhage
|
1.3%
4/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Vomiting
|
0.96%
3/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
1.3%
4/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Asthenia
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Chest Discomfort
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Chest Pain
|
0.96%
3/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Death
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Influenza Like Illness
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Non-Cardiac Chest Pain
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Oedema Peripheral
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Pain
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
1.3%
4/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Pyrexia
|
0.96%
3/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.96%
3/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Hepatobiliary disorders
Cholestasis
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Hepatobiliary disorders
Hepatic Function Abnormal
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Immune system disorders
Food Allergy
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Appendicitis
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Breast Cellulitis
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Bronchitis
|
1.3%
4/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Cellulitis
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.96%
3/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Clostridium Difficile Colitis
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Diverticulitis
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Empyema
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Infection
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Lobar Pneumonia
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Lower Respiratory Tract Infection
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Lung Infection
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Perirectal Abscess
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Pneumonia
|
4.8%
15/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
3.2%
10/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Sepsis
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Septic Shock
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Tracheitis
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Urinary Tract Infection
|
1.3%
4/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Injury, poisoning and procedural complications
Fall
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.96%
3/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Injury, poisoning and procedural complications
Femur Fracture
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Injury, poisoning and procedural complications
Hip Fracture
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Injury, poisoning and procedural complications
Radiation Retinopathy
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Injury, poisoning and procedural complications
Spinal Compression Fracture
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Injury, poisoning and procedural complications
Tibia Fracture
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Injury, poisoning and procedural complications
Tracheal Injury
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Injury, poisoning and procedural complications
Wound Dehiscence
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Investigations
Alanine Aminotransferase Increased
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Investigations
Blood Culture Positive
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Investigations
Heart Rate Increased
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Investigations
International Normalised Ratio Increased
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Investigations
Liver Function Test Abnormal
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Investigations
Platelet Count Decreased
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Metabolism and nutrition disorders
Anorexia
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Metabolism and nutrition disorders
Dehydration
|
2.2%
7/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.96%
3/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Metabolism and nutrition disorders
Diabetic Ketoacidosis
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Metabolism and nutrition disorders
Failure to Thrive
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
1.6%
5/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Musculoskeletal and connective tissue disorders
Bone Pain
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Musculoskeletal and connective tissue disorders
Flank Pain
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Musculoskeletal and connective tissue disorders
Muscular Weakness
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant Pleural Effusion
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Ataxia
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Cerebral Infarction
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Cerebral Ischaemia
|
0.96%
3/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Haemorrhage Intracranial
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Intracranial Pressure Increased
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Ischaemic Stroke
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Neuropathy Peripheral
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Reversible Posterior Leukoencephalopathy Syndrome
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Spinal Cord Compression
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Syncope
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Toxic Encephalopathy
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Transient Ischaemic Attack
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Vocal Cord Paralysis
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Psychiatric disorders
Confusional State
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Psychiatric disorders
Mental Status Changes
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Renal and urinary disorders
Renal Failure
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial Obstruction
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Chronic Obstructive Pulmonary Disease
|
1.9%
6/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
3.8%
12/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
7.7%
24/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea at Rest
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
1.6%
5/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Hydropneumothorax
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
1.3%
4/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Lung Infiltration
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Pleural Effusion
|
0.96%
3/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
2.9%
9/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Embolism
|
3.8%
12/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
2.6%
8/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Haemorrhage
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Oedema
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Distress
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory Failure
|
0.96%
3/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Congestion
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Skin and subcutaneous tissue disorders
Exfoliative Rash
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Skin and subcutaneous tissue disorders
Skin Ulcer
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Vascular disorders
Deep Vein Thrombosis
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
1.9%
6/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Vascular disorders
Hypertension
|
1.3%
4/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Vascular disorders
Hypertensive Crisis
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Vascular disorders
Hypotension
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Vascular disorders
Jugular Vein Thrombosis
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Vascular disorders
Pelvic Venous Thrombosis
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Vascular disorders
Shock
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Vascular disorders
Thrombosis
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Vascular disorders
Trousseau's Syndrome
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Vascular disorders
Venous Thrombosis Limb
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Diarrhoea Infectious
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Cerebrovascular Accident
|
0.64%
2/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Hiatus Hernia
|
0.32%
1/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
0.00%
0/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
Other adverse events
| Measure |
Erlotinib HCl + Bevacizumab
n=313 participants at risk
oral erlotinib HCl 150 mg/day orally + intravenous infusion of bevacizumab at a dose of 15 mg/kg on the first day of each 3-week cycle
|
Erlotinib HCl + Placebo
n=313 participants at risk
oral erlotinib HCl 150 mg/day orally + intravenous infusion of placebo at a dose of 15 mg/kg on the first day of each 3-week cycle
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
6.1%
19/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
9.3%
29/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Diarrhoea
|
64.9%
203/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
51.8%
162/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Nausea
|
38.7%
121/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
31.6%
99/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Vomiting
|
18.2%
57/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
15.7%
49/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Constipation
|
15.7%
49/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
14.4%
45/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Stomatitis
|
12.8%
40/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
8.6%
27/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Abdominal Pain
|
9.3%
29/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
8.0%
25/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
21/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
5.1%
16/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Dysphagia
|
6.1%
19/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
3.8%
12/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Gastrointestinal disorders
Gastrooesophageal Reflux Disease
|
5.8%
18/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
3.2%
10/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Fatigue
|
46.6%
146/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
39.6%
124/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Pyrexia
|
10.5%
33/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
7.3%
23/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Asthenia
|
10.9%
34/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
6.4%
20/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Chest Pain
|
8.6%
27/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
7.7%
24/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Oedema Peripheral
|
5.8%
18/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
10.2%
32/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Mucosal Inflammation
|
11.2%
35/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
5.1%
16/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Pain
|
4.8%
15/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
5.8%
18/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
General disorders
Chills
|
7.3%
23/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
3.5%
11/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Urinary Tract Infection
|
10.5%
33/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
8.3%
26/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
9.6%
30/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
9.6%
30/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Pneumonia
|
2.9%
9/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
5.1%
16/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Bronchitis
|
3.2%
10/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
5.8%
18/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Infections and infestations
Sinusitis
|
5.1%
16/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
2.6%
8/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Investigations
Weight Decreased
|
20.8%
65/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
13.1%
41/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Metabolism and nutrition disorders
Anorexia
|
33.2%
104/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
24.0%
75/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Metabolism and nutrition disorders
Dehydration
|
11.2%
35/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
7.7%
24/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Metabolism and nutrition disorders
Decreased Appetite
|
11.5%
36/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
6.7%
21/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
5.4%
17/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
6.7%
21/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Musculoskeletal and connective tissue disorders
Back Pain
|
14.7%
46/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
13.1%
41/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
11.8%
37/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
8.6%
27/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Pain
|
10.9%
34/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
7.3%
23/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Musculoskeletal and connective tissue disorders
Pain in Extremity
|
7.7%
24/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
6.4%
20/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal Chest Pain
|
6.1%
19/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
4.8%
15/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Musculoskeletal and connective tissue disorders
Muscle Spasms
|
5.1%
16/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
5.4%
17/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Headache
|
16.9%
53/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
8.9%
28/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Dizziness
|
13.1%
41/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
9.9%
31/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Nervous system disorders
Dysgeusia
|
9.3%
29/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
6.1%
19/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Psychiatric disorders
Insomnia
|
12.1%
38/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
8.0%
25/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Psychiatric disorders
Anxiety
|
8.3%
26/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
9.6%
30/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Psychiatric disorders
Depression
|
9.9%
31/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
6.1%
19/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Renal and urinary disorders
Proteinuria
|
5.8%
18/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
2.6%
8/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Renal and urinary disorders
Dysuria
|
5.1%
16/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
1.9%
6/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
23.3%
73/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
24.3%
76/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
19.5%
61/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
20.4%
64/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
20.1%
63/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
9.6%
30/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal Pain
|
8.6%
27/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
4.5%
14/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
10.5%
33/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
1.9%
6/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
7.0%
22/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
4.5%
14/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Wheezing
|
5.4%
17/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
2.9%
9/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea Exertional
|
1.9%
6/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
5.4%
17/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
5.1%
16/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
1.9%
6/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Skin and subcutaneous tissue disorders
Rash
|
61.7%
193/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
58.8%
184/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
20.1%
63/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
18.5%
58/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Skin and subcutaneous tissue disorders
Dermatitis Acneiform
|
18.5%
58/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
13.4%
42/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
15.0%
47/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
12.8%
40/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
5.8%
18/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
5.1%
16/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.1%
16/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
3.5%
11/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Skin and subcutaneous tissue disorders
Skin Exfoliation
|
2.6%
8/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
5.1%
16/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
|
Vascular disorders
Hypertension
|
24.6%
77/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
8.3%
26/313 • From randomization to up to 3.8 years (for Adverse Events) From randomization until last patient last visit or up to 14.5 years from start of study (for Serious Adverse Events)
Safety Evaluable Population
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study.
- Publication restrictions are in place
Restriction type: OTHER