Trial Outcomes & Findings for Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer (NCT NCT00320385)
NCT ID: NCT00320385
Last Updated: 2016-02-26
Results Overview
PFS was defined as the time from randomization until the first documented sign of disease progression or death due to any cause.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
296 participants
Primary outcome timeframe
Baseline to disease progression or death due to any cause or 30 days after last dose (up to 216 weeks)
Results posted on
2016-02-26
Participant Flow
Participant milestones
| Measure |
Trastuzumab + Lapatinib
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
|
Lapatinib
Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
|
|---|---|---|
|
Overall Study
STARTED
|
148
|
148
|
|
Overall Study
COMPLETED
|
130
|
126
|
|
Overall Study
NOT COMPLETED
|
18
|
22
|
Reasons for withdrawal
| Measure |
Trastuzumab + Lapatinib
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
|
Lapatinib
Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
7
|
10
|
|
Overall Study
Withdrawal by Subject
|
6
|
7
|
|
Overall Study
Sponsor Terminated Study
|
2
|
1
|
|
Overall Study
Investigator Decision
|
0
|
1
|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Serious Adverse Event
|
1
|
0
|
|
Overall Study
Withdrew Consent
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
Baseline Characteristics
Lapatinib In Combination With Trastuzumab Versus Lapatinib Monotherapy In Subjects With HER2-positive Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Trastuzumab + Lapatinib
n=148 Participants
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
|
Lapatinib
n=148 Participants
Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
|
Total
n=296 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.1 Years
STANDARD_DEVIATION 11.60 • n=5 Participants
|
51.0 Years
STANDARD_DEVIATION 10.40 • n=7 Participants
|
51.5 Years
STANDARD_DEVIATION 11.01 • n=5 Participants
|
|
Sex: Female, Male
Female
|
148 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
296 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
137 participants
n=5 Participants
|
140 participants
n=7 Participants
|
277 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American/African Heritage
|
6 participants
n=5 Participants
|
5 participants
n=7 Participants
|
11 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 participants
n=5 Participants
|
3 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or other Pacific Islander
|
2 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to disease progression or death due to any cause or 30 days after last dose (up to 216 weeks)Population: Intent-to-Treat (ITT) Population: all randomized participants irrespective of whether or not they actually received study treatment. Only participants with progesterone receptor status were considered for evaluation.
PFS was defined as the time from randomization until the first documented sign of disease progression or death due to any cause.
Outcome measures
| Measure |
Trastuzumab + Lapatinib
n=146 Participants
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
|
Lapatinib
n=145 Participants
Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
12.0 weeks
Interval 8.1 to 16.0
|
8.1 weeks
Interval 7.6 to 9.0
|
SECONDARY outcome
Timeframe: Baseline to death or 30 days after last dose for the last participant (up to 216 weeks)Population: ITT Population. Only participants with progesterone receptor status were considered for evaluation.
OS was defined as the time from randomization until death due to any cause. For participants who did not die, OS was censored at the time of last contact.
Outcome measures
| Measure |
Trastuzumab + Lapatinib
n=146 Participants
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
|
Lapatinib
n=145 Participants
Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
|
|---|---|---|
|
Overall Survival (OS)
|
51.6 weeks
Interval 42.9 to 57.3
|
39.0 weeks
Interval 32.9 to 52.1
|
SECONDARY outcome
Timeframe: Baseline to disease progression or death or discontinuation from study or 30 days after last dose (up to 216 weeks)Population: ITT Population. Only participants with progesterone receptor status were considered for evaluation.
OR was defined as the percentage of participants experiencing either a confirmed complete response (CR) or a confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST) criteria 1.0. CR was defined as the disappearance of all lesions (target and/or non-target). PR was defined as at least a 30% decrease in the sum of the longest dimensions (LD) of target lesions taking as a reference the baseline sum LD, with non-target lesions not increased or absent.
Outcome measures
| Measure |
Trastuzumab + Lapatinib
n=146 Participants
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
|
Lapatinib
n=145 Participants
Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
|
|---|---|---|
|
Overall Tumor Response (OR)
|
10.3 percentage of participants
|
6.9 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline to disease progression or death or discontinuation from study or 30 days after last dose (up to 216 weeks)Population: ITT Population
CBR: percentage of participants with confirmed CR or PR or stable disease (SD) for at least 24 weeks according to RECIST criteria. CR: disappearance of all lesions (target and/or non-target). PR: at least a 30% decrease in the sum of the LD of target lesions taking as reference baseline sum LD, with non-target lesions not increased or absent. SD: neither had sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD) in target lesions, taking as reference the smallest sum LD since treatment started; persistence of 1 or more non-target lesions.
Outcome measures
| Measure |
Trastuzumab + Lapatinib
n=148 Participants
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
|
Lapatinib
n=148 Participants
Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
|
|---|---|---|
|
Clinical Benefit Response (CBR)
|
24.7 percentage of participants
|
12.4 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline until first documented evidence of CR or PR or 30 days after last dose (up to 216 weeks)Population: ITT Population
TTR was defined as the time from randomization until the first documented evidence of CR or PR (whichever status was recorded first). TTR could not be analyzed because too few participants experienced a confirmed CR or PR.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Time from first documented evidence of CR or PR until the first documented sign of disease progression or death or 30 days after last dose (up to 216 weeks)Population: ITT Population
DR was defined for the subset of participants who showed a confirmed CR or PR, as the time from the first documented evidence of CR or PR until the first documented sign of disease progression or death. Because of the low number of participants experiencing a confirmed response in both treatment arms, analysis for this outcome measure was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline to disease progression or death or 30 days after last dose (up to 216 weeks)Population: ITT Population
TTP was defined as the interval between the date of randomization and the earlier of the date of disease progression or death due to breast cancer. Because this outcome measure was confounded by death due to other causes and was similar to PFS, it was not analyzed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Baseline, Week 4, Week 12, Week 16, Week 24, and conclusion or withdrawal from study (up to Week 108)Population: Safety Population: all randomized participants who received \>=1 dose of investigational product. The Safety Population was based on the actual treatment received, if this differed from that to which the participant was randomized. Only participants whose overall item response rate was greater than 80% for the FACT-B total score were considered (n).
Quality of Life (QOL) was assessed using the FACT-B questionnaire, which was a 37-item (27 general and 10 breast cancer-specific questions) self-reporting instrument consisting of 5 dimensions: physical-, social/family-, emotional-, functional-well being, and a breast cancer subscale. Higher scores on the FACT-B scales indicate a higher QOL; each ranging from 0 (not at all) to 4 (very much). The score is transformed for FACT-B and results in a total score ranging from 0 to 144.
Outcome measures
| Measure |
Trastuzumab + Lapatinib
n=137 Participants
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
|
Lapatinib
n=137 Participants
Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
|
|---|---|---|
|
Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores at Week 4, Week 12, Week 16, Week 24, and Conclusion or Withdrawal From Study
Change at Week 16, n=42, 38
|
-0.1 scores on a scale
Standard Deviation 13.34
|
0.4 scores on a scale
Standard Deviation 17.65
|
|
Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores at Week 4, Week 12, Week 16, Week 24, and Conclusion or Withdrawal From Study
Change at Conclusion/Withdrawal, n=63, 67
|
-7.3 scores on a scale
Standard Deviation 15.48
|
-8.0 scores on a scale
Standard Deviation 15.54
|
|
Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores at Week 4, Week 12, Week 16, Week 24, and Conclusion or Withdrawal From Study
Baseline, n=137, 137
|
98.7 scores on a scale
Standard Deviation 21.17
|
97.2 scores on a scale
Standard Deviation 21.85
|
|
Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores at Week 4, Week 12, Week 16, Week 24, and Conclusion or Withdrawal From Study
Change at Week 4, n=101, 109
|
-0.4 scores on a scale
Standard Deviation 11.52
|
-0.6 scores on a scale
Standard Deviation 13.00
|
|
Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores at Week 4, Week 12, Week 16, Week 24, and Conclusion or Withdrawal From Study
Change at Week 12, n=57, 51
|
1.5 scores on a scale
Standard Deviation 10.87
|
-3.0 scores on a scale
Standard Deviation 12.54
|
|
Change From Baseline in Functional Assessment of Cancer Therapy-Breast (FACT-B) Scores at Week 4, Week 12, Week 16, Week 24, and Conclusion or Withdrawal From Study
Change at Week 24, n=28, 28
|
1.3 scores on a scale
Standard Deviation 12.60
|
-1.3 scores on a scale
Standard Deviation 15.67
|
Adverse Events
Trastuzumab + Lapatinib
Serious events: 40 serious events
Other events: 140 other events
Deaths: 0 deaths
Lapatinib
Serious events: 24 serious events
Other events: 132 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trastuzumab + Lapatinib
n=149 participants at risk
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
|
Lapatinib
n=146 participants at risk
Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
1.3%
2/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
2.1%
3/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
3/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
1.4%
2/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Gastrointestinal disorders
Nausea
|
1.3%
2/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
1.4%
2/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Gastrointestinal disorders
Ascites
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Gastrointestinal disorders
Dysphagia
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Gastrointestinal disorders
Flatulence
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Investigations
Ejection fraction decreased
|
4.7%
7/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Investigations
Weight decreased
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Nervous system disorders
Convulsion
|
1.3%
2/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Nervous system disorders
Headache
|
1.3%
2/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Nervous system disorders
Brain oedema
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Nervous system disorders
Hepatic encephalopathy
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Nervous system disorders
Radiculopathy
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
1.3%
2/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Hydrothorax
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Infections and infestations
Pneumonia
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Infections and infestations
Cellulitis
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Infections and infestations
Device related infection
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Infections and infestations
Diverticulitis
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Infections and infestations
Erysipelas
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Infections and infestations
Gastroenteritis
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Infections and infestations
Infection
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Infections and infestations
Sepsis
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
1.4%
2/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Cardiac disorders
Cardiac failure
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Cardiac disorders
Myocardial infarction
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.7%
4/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Metabolism and nutrition disorders
Malnutrition
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Hepatobiliary disorders
Jaundice
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Hepatobiliary disorders
Hepatic failure
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Injury, poisoning and procedural complications
Internal injury
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.3%
2/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Blood and lymphatic system disorders
Anaemia
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to liver
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Psychiatric disorders
Confusional state
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Renal and urinary disorders
Renal failure
|
0.00%
0/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Renal and urinary disorders
Urinary retention
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Vascular disorders
Lymphoedema
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Ear and labyrinth disorders
Vertigo
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
General disorders
Asthenia
|
0.67%
1/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.00%
0/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
Other adverse events
| Measure |
Trastuzumab + Lapatinib
n=149 participants at risk
Participants received Lapatinib 1000 milligram (mg) tablets orally daily 1 hour before or after breakfast along with Trastuzumab infusion at a loading dose of 4 milligrams/kilogram (mg/kg) body weight intravenously (IV) over 90 minutes on Day 1, followed by 2 mg/kg IV over 30 minutes weekly, in a 4 week cycle.
|
Lapatinib
n=146 participants at risk
Participants received Lapatinib 1500 mg tablets orally daily 1 hour before or after breakfast.
|
|---|---|---|
|
Gastrointestinal disorders
Diarrhea
|
61.7%
92/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
47.9%
70/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Gastrointestinal disorders
Nausea
|
28.2%
42/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
28.1%
41/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Skin and subcutaneous tissue disorders
Rash
|
23.5%
35/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
29.5%
43/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
General disorders
Fatigue
|
22.1%
33/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
19.9%
29/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Gastrointestinal disorders
Vomiting
|
14.8%
22/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
17.8%
26/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
13.4%
20/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
14.4%
21/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
12.8%
19/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
9.6%
14/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Nervous system disorders
Headache
|
10.7%
16/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
8.9%
13/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.1%
12/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
5.5%
8/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
8.1%
12/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
5.5%
8/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
General disorders
Asthenia
|
7.4%
11/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
6.8%
10/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.4%
11/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
3.4%
5/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Gastrointestinal disorders
Dyspepsia
|
6.7%
10/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
7.5%
11/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
General disorders
Pyrexia
|
6.7%
10/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
4.8%
7/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Gastrointestinal disorders
Constipation
|
6.0%
9/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
7.5%
11/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
9/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
9.6%
14/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Investigations
Aspartate aminotransferase increased
|
6.0%
9/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
2.1%
3/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Investigations
Ejection fraction decreased
|
6.0%
9/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Gastrointestinal disorders
Abdominal pain
|
5.4%
8/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
4.8%
7/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.4%
8/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
2.1%
3/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Skin and subcutaneous tissue disorders
Dermatitis acneiform
|
5.4%
8/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
9.6%
14/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Investigations
Weight decreased
|
5.4%
8/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
6.2%
9/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Psychiatric disorders
Insomnia
|
5.4%
8/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
0.68%
1/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.7%
7/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
6.8%
10/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.7%
7/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
2.7%
4/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Nervous system disorders
Dizziness
|
4.7%
7/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
1.4%
2/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Blood and lymphatic system disorders
Anaemia
|
4.7%
7/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
2.1%
3/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
General disorders
Oedema peripheral
|
3.4%
5/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
5.5%
8/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.7%
4/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
5.5%
8/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
|
Gastrointestinal disorders
Dry mouth
|
1.3%
2/149 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
4.8%
7/146 • Serious adverse events (SAEs) and non-serious AEs were collected from Baseline to conclusion or withdrawal from study; time from the first dose of treatment until 30 days after the last dose of study treatment (up to 216 weeks).
SAEs and AEs were collected in the Safety Population, which consisted of all randomized participants who received at least one dose of investigational product, and was based on the actual treatment received, if this differed from that to which the participant was randomized.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER