Trial Outcomes & Findings for A Study Comparing the Combination of the Best Supportive Care Plus E7080 Versus Best Supportive Care Alone, in Patients With Advanced Lung Cancer or Lung Cancer That Has Spread, Who Have Been Previously Treated, Unsuccessfully, With at Least 2 Different Treatments (NCT NCT01529112)
NCT ID: NCT01529112
Last Updated: 2017-09-26
Results Overview
OS was defined as the time from the date of randomization until the date of death from any cause.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
135 participants
Primary outcome timeframe
From date of randomization (Day 1) until occurrence of 90 deaths in the study (cut off date 26 November 2013), approximately 22 months
Results posted on
2017-09-26
Participant Flow
The participant flow is based on data cut-off date of 21 January 2014 as the study is ongoing.
Participant milestones
| Measure |
Lenvatinib
Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
|
Lenvatinib Matched Placebo
Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
89
|
46
|
|
Overall Study
COMPLETED
|
20
|
5
|
|
Overall Study
NOT COMPLETED
|
69
|
41
|
Reasons for withdrawal
| Measure |
Lenvatinib
Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
|
Lenvatinib Matched Placebo
Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
|
|---|---|---|
|
Overall Study
Adverse Event
|
2
|
0
|
|
Overall Study
Death
|
59
|
38
|
|
Overall Study
Protocol Violation
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
7
|
3
|
Baseline Characteristics
A Study Comparing the Combination of the Best Supportive Care Plus E7080 Versus Best Supportive Care Alone, in Patients With Advanced Lung Cancer or Lung Cancer That Has Spread, Who Have Been Previously Treated, Unsuccessfully, With at Least 2 Different Treatments
Baseline characteristics by cohort
| Measure |
Lenvatinib
n=89 Participants
Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
|
Lenvatinib Matched Placebo
n=46 Participants
Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63 Years
n=5 Participants
|
63.5 Years
n=7 Participants
|
63 Years
n=5 Participants
|
|
Sex: Female, Male
Female
|
44 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
63 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
72 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From date of randomization (Day 1) until occurrence of 90 deaths in the study (cut off date 26 November 2013), approximately 22 monthsPopulation: The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.
OS was defined as the time from the date of randomization until the date of death from any cause.
Outcome measures
| Measure |
Lenvatinib
n=89 Participants
Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
|
Lenvatinib Matched Placebo
n=46 Participants
Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
|
|---|---|---|
|
Overall Survival (OS)
|
38.4 weeks
Interval 26.57 to 47.86
|
24.1 weeks
Interval 15.29 to 36.43
|
SECONDARY outcome
Timeframe: For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)Population: Safety was analyzed in Safety Analysis Set defined as all subjects enrolled and randomized to treatment in study, except for those who (i) dropped out prior to receiving any study drug, or (ii) were without any safety assessment following the first dose of study drug.
An AE was defined as any untoward medical occurrence in a clinical investigation participant administered with an investigational product. A SAE was defined as any untoward medical occurrence that at any dose; resulted in death, was life-threatening (i.e., the subject was at a risk of death at the time of the event; this did not include an event that hypothetically might have caused death if it had been more severe), required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity or substantial disruption of the ability to conduct normal life functions, or was a congenital abnormality/birth defect. In this study, treatment emergent adverse events (TEAEs) (defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication) were assessed.
Outcome measures
| Measure |
Lenvatinib
n=89 Participants
Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
|
Lenvatinib Matched Placebo
n=46 Participants
Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
|
|---|---|---|
|
Number of Participants With Treatment Emergent Non-serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)
Treatment Emergent Non-Serious AEs
|
83 Participants
|
42 Participants
|
|
Number of Participants With Treatment Emergent Non-serious Adverse Events (AEs) and Treatment Emergent Serious Adverse Events (SAEs)
Treatment Emergent SAEs
|
46 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: From date of randomization (Day 1) up to 6 monthsPopulation: The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.
Event-free survival rate was calculated using Kaplan Meier estimations. The percentage of participants with event free survival up to 6 months and the corresponding 95% confidence interval were estimated for each treatment group. The data presented is based on the data cut-off date of 26 November 2013 while the study is still ongoing.
Outcome measures
| Measure |
Lenvatinib
n=89 Participants
Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
|
Lenvatinib Matched Placebo
n=46 Participants
Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
|
|---|---|---|
|
6-Month Survival Rate
|
61.6 Percentage of Participants
Interval 50.24 to 71.1
|
49 Percentage of Participants
Interval 33.49 to 62.8
|
SECONDARY outcome
Timeframe: From date of randomization (Day 1) up to 1 yearPopulation: The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.
Event-free survival rate was calculated using Kaplan Meier estimations. The percentage of participants with event free survival up to 1 year and the corresponding 95% confidence interval were estimated for each treatment group. The data presented is based on the data cut-off date of 26 November 2013 while the study is still ongoing.
Outcome measures
| Measure |
Lenvatinib
n=89 Participants
Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
|
Lenvatinib Matched Placebo
n=46 Participants
Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
|
|---|---|---|
|
1-year Survival Rate
|
35.8 Percentage of Participants
Interval 25.13 to 46.54
|
20.5 Percentage of Participants
Interval 9.96 to 33.74
|
SECONDARY outcome
Timeframe: From date of randomization (Day 1) until date of first documentation of disease progression or death from any cause (whichever occurred first) or up to approximately 2 years (data cut-off date of 21 January 2014)Population: The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.
PFS was defined as the time from the date of the randomization until the date of first documented disease progression according to Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 or date of death from any cause (whichever occurred first), assessed based on investigator's assessment. Disease progression per RECIST v1.1 was defined as at least a 20% relative increase and 5 mm absolute increase in the sum of diameters of target lesions (taking as reference the smallest sum on study), recorded since the treatment started or the appearance of 1 or more new lesions. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.
Outcome measures
| Measure |
Lenvatinib
n=89 Participants
Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
|
Lenvatinib Matched Placebo
n=46 Participants
Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
|
|---|---|---|
|
Progression-Free Survival (PFS)
|
20.9 weeks
Interval 15.86 to 23.86
|
7.9 weeks
Interval 7.43 to 8.14
|
SECONDARY outcome
Timeframe: From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)Population: The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.
ORR, defined as the percentage of participants who had best overall response (BOR) of complete response (CR) or partial response (PR) as determined by investigator using RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. ORR = CR + PR. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.
Outcome measures
| Measure |
Lenvatinib
n=89 Participants
Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
|
Lenvatinib Matched Placebo
n=46 Participants
Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
|
|---|---|---|
|
Overall Response Rate (ORR)
|
10.1 Percentage of Participants
Interval 4.7 to 18.3
|
2.2 Percentage of Participants
Interval 0.1 to 11.5
|
SECONDARY outcome
Timeframe: From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)Population: The analysis was performed using subjects with events.
Response duration, defined as the time from the date of the first assessment demonstrating a CR or PR to the date of the first assessment demonstrating progressive disease or death, whichever occurred first. This is an investigator assessed outcome, measured using RECIST 1.1. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Response duration was summarized by including only subjects with events. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.
Outcome measures
| Measure |
Lenvatinib
n=6 Participants
Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
|
Lenvatinib Matched Placebo
n=1 Participants
Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
|
|---|---|---|
|
Response Duration (RD)
|
24.2 Weeks
Interval 12.71 to 33.14
|
43.3 Weeks
Not applicable as there was only one participant with event.
|
SECONDARY outcome
Timeframe: From date of randomization (Day 1) until disease progression or death, development of unacceptable toxicity, withdrawal of consent, withdrawal by Investigator, or up to approximately 2 years (data cut-off date of 21 January 2014)Population: The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.
The percentage of participants with CR, PR, or stable disease (SD) for greater than or equal to 12 weeks. CR was defined as disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) had to have reduction in short axis to less than 10 mm. PR was defined as at least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. Stable disease was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on the study. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.
Outcome measures
| Measure |
Lenvatinib
n=89 Participants
Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
|
Lenvatinib Matched Placebo
n=46 Participants
Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
|
|---|---|---|
|
Disease Control Rate (DCR)
|
42.7 Percentage of Participants
Interval 32.3 to 53.6
|
19.6 Percentage of Participants
Interval 9.4 to 33.9
|
SECONDARY outcome
Timeframe: Baseline (Day 1 of Cycle 1 (prior to treatment in Cycle 1)), every 4 weeks during treatment, and 4 weeks after completing treatment or up to approximately 2 years (data cut-off date of 21 January 2014)Population: The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.
The EORTC QLQ-C30 symptom score, a cancer specific self-reporting questionnaire was composed of 9-symptom scales assessing fatigue, nausea and vomiting, pain, dyspnea, insomnia, appetite loss, constipation, diarrhea and financial difficulties. All of the multi-item scales and single-item measures ranged in score from 0 to 100. For each domain and item, a linear transformation was applied to standardize the raw score to a range from 0 to 100, with a higher scale score representing a higher response level/ high level of symptomatology / problems. The data is presented as percentage of participants with EORTC QLQ-C30 symptom score achieving clinically significant deterioration on QOL. Participants were considered as deteriorated for a given symptom if the change in score from Baseline was 10 points or higher at any time point after Baseline. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.
Outcome measures
| Measure |
Lenvatinib
n=89 Participants
Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
|
Lenvatinib Matched Placebo
n=46 Participants
Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
|
|---|---|---|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Symptom Scores Achieving Clinically Significant Deterioration on Quality of Life (QOL)
Appetite Loss (N=82, 39)
|
59.8 Percentage of participants
|
66.7 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Symptom Scores Achieving Clinically Significant Deterioration on Quality of Life (QOL)
Constipation (N=82, 40)
|
43.9 Percentage of participants
|
52.5 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Symptom Scores Achieving Clinically Significant Deterioration on Quality of Life (QOL)
Diarrhea (N=81, 40)
|
48.1 Percentage of participants
|
17.5 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Symptom Scores Achieving Clinically Significant Deterioration on Quality of Life (QOL)
Dyspnea (N=82, 40)
|
43.9 Percentage of participants
|
47.5 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Symptom Scores Achieving Clinically Significant Deterioration on Quality of Life (QOL)
Insomnia (N=82, 40)
|
53.7 Percentage of participants
|
35 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Symptom Scores Achieving Clinically Significant Deterioration on Quality of Life (QOL)
Nausea and Vomiting (N=82, 40)
|
46.3 Percentage of participants
|
40 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Symptom Scores Achieving Clinically Significant Deterioration on Quality of Life (QOL)
Pain (N= 82, 40)
|
74.4 Percentage of participants
|
65 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Symptom Scores Achieving Clinically Significant Deterioration on Quality of Life (QOL)
Fatigue (N= 82, 40)
|
63.4 Percentage of participants
|
67.5 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30 Symptom Scores Achieving Clinically Significant Deterioration on Quality of Life (QOL)
Financial Difficulties (N= 81, 40)
|
34.6 Percentage of participants
|
30 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1 of Cycle 1 (prior to treatment in Cycle 1)), every 4 weeks during treatment, and 4 weeks after completing treatment or up to approximately 2 years (data cut-off date of 21 January 2014)Population: The analysis was performed using the Intent-to-Treat Population, defined as all randomized subjects.
The EORTC module QLQ-LC13 symptom score was a self-reporting cancer-specific questionnaire composed of 13 questions incorporated into 1 multi-item scale designed to evaluate dyspnea and a series of single items assessing different types of pain, as well as, cough, hemoptysis, dysphagia, sore mouth, alopecia, and peripheral neuropathy. For each domain and item, a linear transformation was applied to standardize the raw score to a range from 0 to 100, with 100 representing the best possible function/QOL, and highest burden of symptoms for symptom domains and single items. The data is presented as percentage of participants with EORTC module QLQ-C13 symptom score achieving clinically significant deterioration on QOL. Participants were considered as deteriorated for a given symptom if the change in score from Baseline was 10 points or higher at any time point after Baseline. The data presented is based on the data cut-off date of 21 January 2014 while the study is still ongoing.
Outcome measures
| Measure |
Lenvatinib
n=89 Participants
Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
|
Lenvatinib Matched Placebo
n=46 Participants
Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
|
|---|---|---|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL
Alopecia (Hair Loss) (N= 80, 39)
|
16.3 Percentage of participants
|
15.4 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL
Dysphagia (Trouble Swallowing) (N= 80, 39)
|
43.8 Percentage of participants
|
23.1 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL
Haemoptysis (Coughing Up Blood) (N=80, 39)
|
15 Percentage of participants
|
10.3 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL
How Much Cough (N=80, 39)
|
33.8 Percentage of participants
|
28.2 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL
Medicine For Pain (N=43, 21)
|
41.9 Percentage of participants
|
28.6 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL
Pain In Arm Or Shoulder (N=80, 39)
|
55 Percentage of participants
|
43.6 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL
Pain In Chest (N=80, 39)
|
37.5 Percentage of participants
|
28.2 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL
Pain In Other Parts Of Body (N=79, 39)
|
51.9 Percentage of participants
|
38.5 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL
Peripheral Neuropathy-Tingling Hands/Feet(N=80,39)
|
36.3 Percentage of participants
|
41 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL
Short Of Breath When Climbed Stairs (N=80, 39)
|
45 Percentage of participants
|
46.2 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL
Short Of Breath When Rested (N=80, 39)
|
36.3 Percentage of participants
|
41 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL
Short Of Breath When Walked (N=80, 39)
|
45 Percentage of participants
|
51.3 Percentage of participants
|
|
The Percentage of Participants With The European Organization for Research and Treatment of Cancer (EORTC) Module QLQ-LC13 (Lung Cancer 13) Symptom Scores Achieving Clinically Significant Deterioration on QOL
Sore Mouth Or Tongue (N=80, 39)
|
60 Percentage of participants
|
5.1 Percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1/Day 1 (between 0.5 and 4 hours postdose and 6 and 10 hours postdose), Cycle 1/Day 15 (predose, between 0.5 and 4 hours postdose, and 6 and 10 hours postdose), and Day 1 of Cycles 2 though 4 (predose and between 2 and 12 hours postdose)Population: The analysis was performed using the pharmacokinetic (PK) analysis set defined as all subjects who received at least one dose of study drug and had evaluable PK data.
Blood samples were collected for lenvatinib PK analysis. Lenvatinib concentrations from sparse PK sampling were measured. The data is presented as mean nanograms per milliliter +/- Standard deviation of lenvatinib serum concentration.
Outcome measures
| Measure |
Lenvatinib
n=67 Participants
Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
|
Lenvatinib Matched Placebo
Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
|
|---|---|---|
|
Pharmacokinetic (PK) Profile of Lenvatinib in Subjects With Non Small Cell Lung Cancer (NSCLC)
Cycle 1 Day 1 (0.5 to 4 hours postdose); N=47
|
93.4 nanograms per milliliter
Standard Deviation 125.66
|
—
|
|
Pharmacokinetic (PK) Profile of Lenvatinib in Subjects With Non Small Cell Lung Cancer (NSCLC)
Cycle 1 Day 1 (6 to 10 hours postdose); N=46
|
229.0 nanograms per milliliter
Standard Deviation 114.06
|
—
|
|
Pharmacokinetic (PK) Profile of Lenvatinib in Subjects With Non Small Cell Lung Cancer (NSCLC)
Cycle 1 Day 15 (Pre-dose); N=43
|
77.8 nanograms per milliliter
Standard Deviation 84.73
|
—
|
|
Pharmacokinetic (PK) Profile of Lenvatinib in Subjects With Non Small Cell Lung Cancer (NSCLC)
Cycle 1 Day 15 (0.5 to 4 hours postdose); N=44
|
134.3 nanograms per milliliter
Standard Deviation 119.44
|
—
|
|
Pharmacokinetic (PK) Profile of Lenvatinib in Subjects With Non Small Cell Lung Cancer (NSCLC)
Cycle 1 Day 15 (6 to 10 hours postdose); N=39
|
230.7 nanograms per milliliter
Standard Deviation 106.29
|
—
|
|
Pharmacokinetic (PK) Profile of Lenvatinib in Subjects With Non Small Cell Lung Cancer (NSCLC)
Cycle 2 Day 1 (Pre-dose); N=42
|
68.6 nanograms per milliliter
Standard Deviation 73.53
|
—
|
|
Pharmacokinetic (PK) Profile of Lenvatinib in Subjects With Non Small Cell Lung Cancer (NSCLC)
Cycle 2 Day 1 (2 to 12 hours postdose); N=41
|
260.4 nanograms per milliliter
Standard Deviation 176.26
|
—
|
|
Pharmacokinetic (PK) Profile of Lenvatinib in Subjects With Non Small Cell Lung Cancer (NSCLC)
Cycle 3 Day 1 (Pre-dose); N=34
|
53.5 nanograms per milliliter
Standard Deviation 49.20
|
—
|
|
Pharmacokinetic (PK) Profile of Lenvatinib in Subjects With Non Small Cell Lung Cancer (NSCLC)
Cycle 3 Day 1 (2 to 12 hours postdose); N=31
|
255.3 nanograms per milliliter
Standard Deviation 173.79
|
—
|
|
Pharmacokinetic (PK) Profile of Lenvatinib in Subjects With Non Small Cell Lung Cancer (NSCLC)
Cycle 4 Day 1 (Pre-dose); N=29
|
46.2 nanograms per milliliter
Standard Deviation 34.94
|
—
|
|
Pharmacokinetic (PK) Profile of Lenvatinib in Subjects With Non Small Cell Lung Cancer (NSCLC)
Cycle 4 Day 1 (2 to 12 hours postdose); N=27
|
217.7 nanograms per milliliter
Standard Deviation 167.70
|
—
|
Adverse Events
Lenvatinib
Serious events: 46 serious events
Other events: 83 other events
Deaths: 0 deaths
Lenvatinib Matched Placebo
Serious events: 21 serious events
Other events: 42 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lenvatinib
n=89 participants at risk
Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
|
Lenvatinib Matched Placebo
n=46 participants at risk
Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Blood and lymphatic system disorders
NEUTROPENIA
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Cardiac disorders
CARDIAC FAILURE
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Cardiac disorders
CARDIO-RESPIRATORY ARREST
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Cardiac disorders
PULSELESS ELECTRICAL ACTIVITY
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Endocrine disorders
INAPPROPRIATE ANTIDIURETIC HORMONE SECRETION
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
STOMATITIS
|
2.2%
2/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
CONSTIPATION
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
DIARRHOEA
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
VOMITING
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
ASCITES
|
0.00%
0/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
OESOPHAGEAL STENOSIS
|
0.00%
0/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
General disorders
GENERAL PHYSICAL HEALTH DETERIORATION
|
4.5%
4/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
6.5%
3/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
General disorders
CHEST PAIN
|
3.4%
3/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
General disorders
ASTHENIA
|
2.2%
2/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
General disorders
PERFORMANCE STATUS DECREASED
|
2.2%
2/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
General disorders
FATIGUE
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
General disorders
MULTI-ORGAN FAILURE
|
0.00%
0/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Hepatobiliary disorders
CHOLECYSTITIS
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Hepatobiliary disorders
HEPATITIS ACUTE
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Infections and infestations
PNEUMONIA
|
7.9%
7/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
6.5%
3/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Infections and infestations
LOWER RESPIRATORY TRACT INFECTION
|
2.2%
2/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Infections and infestations
SEPSIS
|
2.2%
2/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Infections and infestations
BRONCHITIS
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Infections and infestations
DEVICE RELATED INFECTION
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Infections and infestations
INFECTION
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Infections and infestations
OESOPHAGEAL CANDIDIASIS
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Infections and infestations
TOOTH ABSCESS
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Infections and infestations
RESPIRATORY TRACT INFECTION
|
0.00%
0/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Metabolism and nutrition disorders
DEHYDRATION
|
2.2%
2/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Metabolism and nutrition disorders
HYPONATRAEMIA
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Metabolism and nutrition disorders
CACHEXIA
|
0.00%
0/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
MYOPATHY
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
0.00%
0/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
METASTASES TO CENTRAL NERVOUS SYSTEM
|
2.2%
2/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Nervous system disorders
HAEMORRHAGE INTRACRANIAL
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Nervous system disorders
QUADRIPARESIS
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Nervous system disorders
DEPRESSED LEVEL OF CONSCIOUSNESS
|
0.00%
0/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Psychiatric disorders
HALLUCINATION
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Psychiatric disorders
SUICIDE ATTEMPT
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Psychiatric disorders
COMPLETED SUICIDE
|
0.00%
0/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Psychiatric disorders
CONFUSIONAL STATE
|
0.00%
0/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Renal and urinary disorders
NEPHROTIC SYNDROME
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
7.9%
7/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
8.7%
4/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
3.4%
3/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
PNEUMOTHORAX
|
3.4%
3/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
BRONCHIAL POLYP
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
PLEURAL EFFUSION
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY EMBOLISM
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
RESPIRATORY ARREST
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
0.00%
0/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
PULMONARY HAEMORRHAGE
|
0.00%
0/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Skin and subcutaneous tissue disorders
SUBCUTANEOUS EMPHYSEMA
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
Other adverse events
| Measure |
Lenvatinib
n=89 participants at risk
Participants received lenvatinib 24 mg orally, once daily continuously in each 28-day treatment cycle.
|
Lenvatinib Matched Placebo
n=46 participants at risk
Participants received lenvatinib matched placebo orally, once daily continuously in each 28-day treatment cycle.
|
|---|---|---|
|
Blood and lymphatic system disorders
ANAEMIA
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
6.5%
3/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Blood and lymphatic system disorders
THROMBOCYTOPENIA
|
5.6%
5/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
ABDOMINAL DISCOMFORT
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
6.5%
3/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN
|
16.9%
15/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
ABDOMINAL PAIN UPPER
|
5.6%
5/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
CONSTIPATION
|
19.1%
17/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
17.4%
8/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
DIARRHOEA
|
30.3%
27/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
6.5%
3/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
DRY MOUTH
|
7.9%
7/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
4.3%
2/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
DYSPEPSIA
|
14.6%
13/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
NAUSEA
|
29.2%
26/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
13.0%
6/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
STOMATITIS
|
30.3%
27/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
8.7%
4/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Gastrointestinal disorders
VOMITING
|
25.8%
23/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
6.5%
3/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
General disorders
ASTHENIA
|
18.0%
16/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
General disorders
CHEST PAIN
|
9.0%
8/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
13.0%
6/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
General disorders
FATIGUE
|
27.0%
24/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
17.4%
8/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
General disorders
MALAISE
|
5.6%
5/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
General disorders
MUCOSAL INFLAMMATION
|
5.6%
5/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
General disorders
OEDEMA PERIPHERAL
|
10.1%
9/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
4.3%
2/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
General disorders
PAIN
|
1.1%
1/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
6.5%
3/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
General disorders
PYREXIA
|
11.2%
10/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
8.7%
4/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Investigations
PLATELET COUNT DECREASED
|
7.9%
7/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Investigations
WEIGHT DECREASED
|
14.6%
13/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Metabolism and nutrition disorders
DECREASED APPETITE
|
34.8%
31/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
23.9%
11/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
ARTHRALGIA
|
19.1%
17/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
10.9%
5/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
BACK PAIN
|
14.6%
13/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
6.5%
3/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
MUSCULAR WEAKNESS
|
5.6%
5/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
MUSCULOSKELETAL PAIN
|
9.0%
8/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
6.5%
3/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
MYALGIA
|
11.2%
10/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Musculoskeletal and connective tissue disorders
PAIN IN EXTREMITY
|
5.6%
5/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Nervous system disorders
HEADACHE
|
19.1%
17/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
13.0%
6/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Nervous system disorders
LETHARGY
|
7.9%
7/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
4.3%
2/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Psychiatric disorders
ANXIETY
|
4.5%
4/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
6.5%
3/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Psychiatric disorders
INSOMNIA
|
7.9%
7/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
6.5%
3/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Renal and urinary disorders
PROTEINURIA
|
37.1%
33/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
6.5%
3/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
COUGH
|
18.0%
16/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
21.7%
10/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPHONIA
|
21.3%
19/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
DYSPNOEA
|
18.0%
16/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
8.7%
4/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
HAEMOPTYSIS
|
7.9%
7/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
OROPHARYNGEAL PAIN
|
6.7%
6/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
PRODUCTIVE COUGH
|
11.2%
10/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
8.7%
4/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Respiratory, thoracic and mediastinal disorders
RHINORRHOEA
|
5.6%
5/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Skin and subcutaneous tissue disorders
DRY SKIN
|
10.1%
9/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Skin and subcutaneous tissue disorders
PALMAR-PLANTAR ERYTHRODYSAESTHESIA SYNDROME
|
15.7%
14/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
0.00%
0/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Skin and subcutaneous tissue disorders
PRURITUS
|
10.1%
9/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
2.2%
1/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Skin and subcutaneous tissue disorders
RASH
|
5.6%
5/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
4.3%
2/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
|
Vascular disorders
HYPERTENSION
|
44.9%
40/89 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
8.7%
4/46 • For each participant, from the first dose till 30 days after the last dose or up to approximately 2 years (data cut-off date of 21 January 2014)
Treatment emergent adverse events (TEAEs), defined as an AE (serious/non-serious) that started/increased in severity on/after the first dose of study medication up to 30 days after the final dose of study medication are presented in this section.
|
Additional Information
Eisai Inc.
Eisai Call Center
Phone: 888-422-4743
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER