Trial Outcomes & Findings for AVAPERL1 Study: A Study of Avastin (Bevacizumab) With or Without Pemetrexed as Maintenance Therapy After Avastin in First Line in Patients With Non-Squamous Non-Small Cell Lung Cancer (NCT NCT00961415)
NCT ID: NCT00961415
Last Updated: 2016-02-22
Results Overview
Progression free survival (PFS) is defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) , or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Progression is defined using (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
376 participants
Primary outcome timeframe
Up to 21 months
Results posted on
2016-02-22
Participant Flow
A total of 414 participants were screened out of which 38 participants were excluded for not meeting the eligibility criteria, declining to participate, or for other reasons. A total of 376 participants were recruited over an 18-month period across 81 centers in 11 countries from 17 August 2009 to 3 May 2011.
Of the 376 participants enrolled in this study, 3 participants did not start induction phase treatment.
Participant milestones
| Measure |
Induction Treatment Phase
Bevacizumab 7.5 milligram (mg)/ kilogram (kg) + cisplatin 75 mg/m\^2 + pemetrexed 500 mg/m\^2 was administered intravenously (IV) every 3 weeks. Participants received 4 cycles of induction therapy.
|
Bevacizumab Maintenance Treatment (Trt) Arm A
Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
Bevacizumab +Pemetrexed Maintenance Trt Arm B
Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m\^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram \[mcg\] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
|---|---|---|---|
|
Induction Treatment Phase
STARTED
|
376
|
0
|
0
|
|
Induction Treatment Phase
COMPLETED
|
253
|
0
|
0
|
|
Induction Treatment Phase
NOT COMPLETED
|
123
|
0
|
0
|
|
Maintenance Treatment Phase
STARTED
|
0
|
125
|
128
|
|
Maintenance Treatment Phase
COMPLETED
|
0
|
77
|
83
|
|
Maintenance Treatment Phase
NOT COMPLETED
|
0
|
48
|
45
|
Reasons for withdrawal
| Measure |
Induction Treatment Phase
Bevacizumab 7.5 milligram (mg)/ kilogram (kg) + cisplatin 75 mg/m\^2 + pemetrexed 500 mg/m\^2 was administered intravenously (IV) every 3 weeks. Participants received 4 cycles of induction therapy.
|
Bevacizumab Maintenance Treatment (Trt) Arm A
Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
Bevacizumab +Pemetrexed Maintenance Trt Arm B
Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m\^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram \[mcg\] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
|---|---|---|---|
|
Induction Treatment Phase
Withdrawal by Subject
|
11
|
0
|
0
|
|
Induction Treatment Phase
Death
|
77
|
0
|
0
|
|
Induction Treatment Phase
Protocol Violation
|
1
|
0
|
0
|
|
Induction Treatment Phase
Physician Decision
|
2
|
0
|
0
|
|
Induction Treatment Phase
Didn't meet maintenance phase criteria
|
27
|
0
|
0
|
|
Induction Treatment Phase
Other Reason
|
5
|
0
|
0
|
|
Maintenance Treatment Phase
Death
|
0
|
42
|
34
|
|
Maintenance Treatment Phase
Investigators decision
|
0
|
2
|
0
|
|
Maintenance Treatment Phase
Withdrawal by Subject
|
0
|
3
|
8
|
|
Maintenance Treatment Phase
Other reason
|
0
|
1
|
3
|
Baseline Characteristics
AVAPERL1 Study: A Study of Avastin (Bevacizumab) With or Without Pemetrexed as Maintenance Therapy After Avastin in First Line in Patients With Non-Squamous Non-Small Cell Lung Cancer
Baseline characteristics by cohort
| Measure |
Bevacizumab Maintenance Trt Arm A
n=125 Participants
Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
Bevacizumab +Pemetrexed Maintenance Trt Arm B
n=128 Participants
Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m\^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram \[mcg\] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
Total
n=253 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.5 years
STANDARD_DEVIATION 8.25 • n=5 Participants
|
59.3 years
STANDARD_DEVIATION 8.86 • n=7 Participants
|
59.4 years
STANDARD_DEVIATION 8.55 • n=5 Participants
|
|
Sex: Female, Male
Female
|
55 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
70 Participants
n=5 Participants
|
74 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 21 monthsPopulation: The ITT population included all the participants that were randomized.
Progression free survival (PFS) is defined as the time from randomization to the date of documented disease progression according to Response Evaluation Criteria in Solid Tumors (RECIST v1.1) , or the date of occurrence of a second primary cancer, or date of death from any cause, whichever comes first. Progression is defined using (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, the appearance of new lesions and increase of at least 5 mm in the sum of diameters of target lesions.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.
Outcome measures
| Measure |
Bevacizumab Maintenance Trt Arm A
n=125 Participants
Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
Bevacizumab +Pemetrexed Maintenance Trt Arm B
n=128 Participants
Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m\^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram \[mcg\] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
No Maintenance Trt
A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm.
|
|---|---|---|---|
|
Progression Free Survival During Maintenance Treatment Phase
|
6.6 Months
Interval 6.0 to 7.8
|
10.2 Months
Interval 9.1 to 11.7
|
—
|
SECONDARY outcome
Timeframe: Up to 21 monthsPopulation: The ITT population included all the participants that were randomized.
Overall survival (OS) is assessed from the date of first induction treatment until the date of death. Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.
Outcome measures
| Measure |
Bevacizumab Maintenance Trt Arm A
n=125 Participants
Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
Bevacizumab +Pemetrexed Maintenance Trt Arm B
n=128 Participants
Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m\^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram \[mcg\] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
No Maintenance Trt
A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm.
|
|---|---|---|---|
|
Overall Survival During Maintenance Treatment Phase
|
15.7 Months
Interval 14.3 to
Data unavailable, as the follow-up time was very short to observe enough survival events.
|
NA Months
Data unavailable, as the follow-up time was very short to observe enough survival events.
|
—
|
SECONDARY outcome
Timeframe: Up to 21 monthsPopulation: The ITT population which included all the participants that were randomized.
The best overall response rate (BORR) is defined as the percentage of participants having achieved confirmed Complete Response (CR) and Partial Response (PR) as the best overall response. CR was defined as complete disappearance of all target lesions and non-target disease. PR was defined as a greater than or equal to (≥) 30% decrease under baseline of the sum of diameters of all target lesions. Stable disease (SD) is defined as steady state of disease with neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD).Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.
Outcome measures
| Measure |
Bevacizumab Maintenance Trt Arm A
n=125 Participants
Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
Bevacizumab +Pemetrexed Maintenance Trt Arm B
n=128 Participants
Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m\^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram \[mcg\] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
No Maintenance Trt
A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm.
|
|---|---|---|---|
|
Best Overall Response Rate During Maintenance Treatment Phase
Partial response (PR)
|
50 percentage of participants
Interval 40.9 to 59.1
|
55.5 percentage of participants
Interval 46.4 to 64.3
|
—
|
|
Best Overall Response Rate During Maintenance Treatment Phase
Stable disease (SD)
|
50 percentage of participants
Interval 40.9 to 59.1
|
44.5 percentage of participants
Interval 35.7 to 53.6
|
—
|
SECONDARY outcome
Timeframe: Up to 21 monthsPopulation: The ITT population included all the participants that were randomized.Participants available at particular time point for assessment were included in the analysis.
Duration of response is defined as the time in months from the initial start of response PR or better to the earlier of documented PD or death due to any cause. Participants who had neither progressed nor died at the date of clinical cutoff, who withdrew from the study, were lost to follow-up, or were without documented disease progression were censored at the date of the last available tumor assessment. The analysis was based on all participants with measurable disease at baseline who achieved response.Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.
Outcome measures
| Measure |
Bevacizumab Maintenance Trt Arm A
n=62 Participants
Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
Bevacizumab +Pemetrexed Maintenance Trt Arm B
n=71 Participants
Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m\^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram \[mcg\] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
No Maintenance Trt
A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm.
|
|---|---|---|---|
|
Duration of Response During Maintenance Treatment Phase
|
5.7 Months
Interval 4.9 to 7.2
|
9.2 Months
Interval 6.8 to 10.4
|
—
|
SECONDARY outcome
Timeframe: Up to 21 monthsPopulation: The ITT population included all the participants that were randomized.
Duration of disease control is defined as the time in months from randomization to the earlier of documented PD or death due to any cause. Tumor assessment was done before Cycle 3, at Cycle 2 of maintenance therapy and every nine weeks thereafter.
Outcome measures
| Measure |
Bevacizumab Maintenance Trt Arm A
n=125 Participants
Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
Bevacizumab +Pemetrexed Maintenance Trt Arm B
n=128 Participants
Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m\^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram \[mcg\] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
No Maintenance Trt
A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm.
|
|---|---|---|---|
|
Duration of Disease Control During Maintenance Treatment Phase
|
4.9 Months
Interval 3.9 to 5.7
|
7.8 Months
Interval 6.8 to 9.7
|
—
|
SECONDARY outcome
Timeframe: Up to 21 monthsPopulation: The safety population comprised of all participants who received at least one dose of study medication. Participants who received induction treatment and were not randomised to maintenance treatment are also included in analysis.
An adverse events (AE) is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not considered related to the medicinal (investigational) product. An serious adverse event (SAE) is any experience that suggests a significant hazard, contraindication, side effect, or precaution.
Outcome measures
| Measure |
Bevacizumab Maintenance Trt Arm A
n=120 Participants
Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
Bevacizumab +Pemetrexed Maintenance Trt Arm B
n=125 Participants
Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m\^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram \[mcg\] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
No Maintenance Trt
n=128 Participants
A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm.
|
|---|---|---|---|
|
Incidence of Adverse Events and Serious Adverse Event
AE
|
116 Participants
|
123 Participants
|
119 Participants
|
|
Incidence of Adverse Events and Serious Adverse Event
SAE
|
26 Participants
|
42 Participants
|
70 Participants
|
SECONDARY outcome
Timeframe: Up to 21 monthsPopulation: The safety population comprised of all participants who received at least one dose of study medication. Participants who received induction treatment and were not randomised to maintenance treatment are also included in analysis.
Marked laboratory abnormalities were defined as those values that were outside the reference range and showed a clinically relevant change from Baseline. The reference range for Platelets was 100-550 (10\^9/L), for White blood cells (WBC) was 3.0-18.0 (10\^9/L), for Lymphocytes was 0.70-7.60 (10\^9/L), and Neutrophil 1.50-9.25 (10\^9/L ).
Outcome measures
| Measure |
Bevacizumab Maintenance Trt Arm A
n=120 Participants
Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
Bevacizumab +Pemetrexed Maintenance Trt Arm B
n=125 Participants
Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m\^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram \[mcg\] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
No Maintenance Trt
n=128 Participants
A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm.
|
|---|---|---|---|
|
Number of Participants With Marked Laboratory Abnormalities
Alanine amino transferase (ALT)
|
18 Participants
|
26 Participants
|
8 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Aspartate amino transferase (AST)
|
18 Participants
|
26 Participants
|
8 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Alkaline phosphatase
|
18 Participants
|
26 Participants
|
8 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Hemoglobin
|
28 Participants
|
30 Participants
|
25 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
International normalized ratio (INR)
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Lymphocytes
|
28 Participants
|
30 Participants
|
25 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Neutrophils
|
28 Participants
|
30 Participants
|
25 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Platelets
|
28 Participants
|
30 Participants
|
25 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Serum creatinine
|
18 Participants
|
26 Participants
|
8 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
WBC
|
28 Participants
|
30 Participants
|
25 Participants
|
|
Number of Participants With Marked Laboratory Abnormalities
Activated partial thromboplastin time (aPTT)
|
1 Participants
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 21 monthsPopulation: The ITT population included all the participants that were randomized.
European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Cancer 30 (EORTC QLQ-C30): included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties). The European Organization for Research and Treatment of Cancer Quality-of-Life Questionnaire-Lung Cancer 13 \[EORTC QLQ-LC13\]consisted of 1 multi-item scale and 9 single items that assessed the specific symptoms (dyspnea, cough, hemoptysis, and site specific pain), side effects (sore mouth, dysphagia, neuropathy, and alopecia), and pain medication use of lung cancer participants receiving chemotherapy. Scale score range: 0 to 100. Higher symptom score = greater degree of symptom severity. QOL was assessed using Pre-Induction Baseline (Pre-ind BL), Maintenance (MTC), End of study (EOS) cycles.
Outcome measures
| Measure |
Bevacizumab Maintenance Trt Arm A
n=125 Participants
Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. The first cycle of maintenance therapy had to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
Bevacizumab +Pemetrexed Maintenance Trt Arm B
n=128 Participants
Bevacizumab 7.5 mg/kg + pemetrexed 500 mg/m\^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Pemetrexed-treated participants received standard supplementation with folic acid orally (350 to 1000 microgram \[mcg\] daily), vitamin B12 intramuscularly (1000 mcg every 3 cycles), and dexamethasone prophylaxis orally (4 mg twice a day) on Days -1, 1, and 2 of each cycle. The first cycle of maintenance therapy was to be administered a maximum of 4 weeks after the fourth cycle of induction therapy.
|
No Maintenance Trt
A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm.
|
|---|---|---|---|
|
Quality of Life
[MTC Cycle 9 ]Dyspnea Symptom Scale (n=32,50)
|
25.0 Score on scale
Standard Deviation 25.40
|
35.3 Score on scale
Standard Deviation 27.28
|
—
|
|
Quality of Life
MTC Cycle 3]Appetite Loss Symptom Scale (n=69,87)
|
13.5 Score on scale
Standard Deviation 22.37
|
18.4 Score on scale
Standard Deviation 25.80
|
—
|
|
Quality of Life
[MTC Cycle 3]Insomnia Symptom Scale (n=69,87)
|
19.3 Score on scale
Standard Deviation 24.53
|
19.5 Score on scale
Standard Deviation 25.19
|
—
|
|
Quality of Life
[MTC Cycle 3]Constipation Symptom Scale (n=69,87)
|
10.1 Score on scale
Standard Deviation 19.22
|
11.1 Score on scale
Standard Deviation 20.12
|
—
|
|
Quality of Life
[MTC Cycle 3]Diarrhea Symptom Scale (n=69,87)
|
3.4 Score on scale
Standard Deviation 12.97
|
5.7 Score on scale
Standard Deviation 14.56
|
—
|
|
Quality of Life
[MTC Cycle 3]Financial Difficulties Scale (n=68,86
|
18.1 Score on scale
Standard Deviation 27.88
|
19.4 Score on scale
Standard Deviation 26.30
|
—
|
|
Quality of Life
[MTC Cycle 5] Global Health Status (n=51,77)
|
63.2 Score on scale
Standard Deviation 20.36
|
62.9 Score on scale
Standard Deviation 18.81
|
—
|
|
Quality of Life
[MTC Cycle 5] Physical Functional Scale (n=51,77)
|
78.7 Score on scale
Standard Deviation 21.29
|
78.4 Score on scale
Standard Deviation 15.45
|
—
|
|
Quality of Life
[MTC Cycle 5] Role Functional Scale (n=51,77)
|
74.5 Score on scale
Standard Deviation 31.15
|
68.8 Score on scale
Standard Deviation 27.08
|
—
|
|
Quality of Life
[MTC Cycle 5] Emotional Functional Scale (n=51,77)
|
78.8 Score on scale
Standard Deviation 23.76
|
78.7 Score on scale
Standard Deviation 20.96
|
—
|
|
Quality of Life
[MTC Cycle 5] Cognitive Functional Scale (n=51,77)
|
81.0 Score on scale
Standard Deviation 26.04
|
84.6 Score on scale
Standard Deviation 18.09
|
—
|
|
Quality of Life
[MTC Cycle 5] Social Functional Scale (n=51,77)
|
85.3 Score on scale
Standard Deviation 22.52
|
77.9 Score on scale
Standard Deviation 22.85
|
—
|
|
Quality of Life
[MTC Cycle 5] Fatigue Symptom Scale (n=51,77)
|
32.2 Score on scale
Standard Deviation 23.01
|
34.5 Score on scale
Standard Deviation 22.12
|
—
|
|
Quality of Life
[MTC Cycle 5] Nausea and Vomiting Scale (n=51,77)
|
9.2 Score on scale
Standard Deviation 18.05
|
10.0 Score on scale
Standard Deviation 20.10
|
—
|
|
Quality of Life
[MTC Cycle 5] Pain Symptom Scale (n=51,77)
|
23.5 Score on scale
Standard Deviation 26.28
|
20.1 Score on scale
Standard Deviation 25.27
|
—
|
|
Quality of Life
[MTC Cycle 5] Dyspnea Symptom Scale (n=51,77)
|
25.5 Score on scale
Standard Deviation 27.96
|
35.9 Score on scale
Standard Deviation 30.95
|
—
|
|
Quality of Life
[MTC Cycle 5] Insomnia Symptom Scale( n=51,77)
|
21.6 Score on scale
Standard Deviation 28.92
|
22.1 Score on scale
Standard Deviation 27.36
|
—
|
|
Quality of Life
MTC Cycle 5] Appetite Loss Symptom Scale (n=51,77)
|
10.5 Score on scale
Standard Deviation 19.43
|
19.9 Score on scale
Standard Deviation 26.63
|
—
|
|
Quality of Life
[MTC Cycle 5] Constipation Symptom Scale (n=51,77)
|
9.2 Score on scale
Standard Deviation 20.09
|
17.3 Score on scale
Standard Deviation 29.42
|
—
|
|
Quality of Life
[MTC Cycle 5] Diarrhea Symptom Scale (n=51,77)
|
10.5 Score on scale
Standard Deviation 20.54
|
2.6 Score on scale
Standard Deviation 8.99
|
—
|
|
Quality of Life
[MTC Cycle 5] Financial Difficulties Scale n=50,77
|
16.0 Score on scale
Standard Deviation 28.76
|
17.7 Score on scale
Standard Deviation 23.31
|
—
|
|
Quality of Life
[MTC Cycle 7] Global Health Status Scale (n=38,64)
|
61.2 Score on scale
Standard Deviation 21.69
|
61.3 Score on scale
Standard Deviation 19.55
|
—
|
|
Quality of Life
[MTC Cycle 7] Physical Functional Scale (n=38,64)
|
75.6 Score on scale
Standard Deviation 21.49
|
74.7 Score on scale
Standard Deviation 19.38
|
—
|
|
Quality of Life
[MTC Cycle 7]Role Functional Scale (n=38,64)
|
76.8 Score on scale
Standard Deviation 24.97
|
70.8 Score on scale
Standard Deviation 28.79
|
—
|
|
Quality of Life
[MTC Cycle 7]Emotional Functional Scale (n=38,64)
|
81.6 Score on scale
Standard Deviation 22.27
|
77.5 Score on scale
Standard Deviation 18.64
|
—
|
|
Quality of Life
[MTC Cycle 7]Cognitive Functional Scale (n=38,64)
|
77.2 Score on scale
Standard Deviation 27.51
|
81.0 Score on scale
Standard Deviation 18.98
|
—
|
|
Quality of Life
[MTC Cycle 7]Social Functional Scale (n=38,64)
|
82.9 Score on scale
Standard Deviation 24.35
|
72.1 Score on scale
Standard Deviation 28.65
|
—
|
|
Quality of Life
[MTC Cycle 7]Fatigue Symptom Scale (n=38,64)
|
32.3 Score on scale
Standard Deviation 22.07
|
33.7 Score on scale
Standard Deviation 24.72
|
—
|
|
Quality of Life
[MTC Cycle 7]Nausea & Vomiting Scale (n=38,64)
|
8.3 Score on scale
Standard Deviation 18.88
|
9.6 Score on scale
Standard Deviation 16.48
|
—
|
|
Quality of Life
[MTC Cycle 7]Pain Symptom Scale (n=38,64)
|
21.5 Score on scale
Standard Deviation 23.86
|
19.8 Score on scale
Standard Deviation 23.55
|
—
|
|
Quality of Life
[MTC Cycle 7]Dyspnea Symptom Scale (n=38,64)
|
28.1 Score on scale
Standard Deviation 26.31
|
37 Score on scale
Standard Deviation 32.59
|
—
|
|
Quality of Life
[MTC Cycle 7]Insomnia Symptom Scale (n=38,64)
|
16.7 Score on scale
Standard Deviation 26.57
|
28.6 Score on scale
Standard Deviation 30.21
|
—
|
|
Quality of Life
[MTC Cycle 7]Appetite Loss Scale (n=38,64)
|
12.3 Score on scale
Standard Deviation 21.11
|
21.4 Score on scale
Standard Deviation 29.32
|
—
|
|
Quality of Life
[MTC Cycle 7]Constipation Symptom Scale (n=38,64)
|
14 Score on scale
Standard Deviation 28.61
|
17.2 Score on scale
Standard Deviation 24.48
|
—
|
|
Quality of Life
[MTC Cycle 7]Diarrhea Symptom Scale (n=38,64)
|
8.8 Score on scale
Standard Deviation 20.04
|
8.9 Score on scale
Standard Deviation 21.61
|
—
|
|
Quality of Life
[MTC Cycle 7]Financial Difficulties Scale n=38,64
|
14.0 Score on scale
Standard Deviation 24.05
|
20.3 Score on scale
Standard Deviation 27.61
|
—
|
|
Quality of Life
[MTC Cycle 9 ]Global Health Status Scale (n=33,50)
|
60.6 Score on scale
Standard Deviation 18.67
|
61.2 Score on scale
Standard Deviation 17.71
|
—
|
|
Quality of Life
[MTC Cycle 9 ]Physical Functional Scale (n=33,50)
|
80.8 Score on scale
Standard Deviation 20.53
|
74.9 Score on scale
Standard Deviation 19.54
|
—
|
|
Quality of Life
[MTC Cycle 9 ]Role Functional Scale (n=33,50)
|
75.8 Score on scale
Standard Deviation 24.33
|
69.7 Score on scale
Standard Deviation 28.51
|
—
|
|
Quality of Life
[MTC Cycle 9 ]Emotional Functional Scale (n=33,50)
|
82.3 Score on scale
Standard Deviation 18.61
|
75 Score on scale
Standard Deviation 22.46
|
—
|
|
Quality of Life
[MTC Cycle 9 ]Cognitive Functional Scale (n=33,50)
|
83.3 Score on scale
Standard Deviation 20.41
|
81.7 Score on scale
Standard Deviation 19.99
|
—
|
|
Quality of Life
[MTC Cycle 9 ]Social Functional Scale (n=33,50)
|
83.8 Score on scale
Standard Deviation 24.47
|
71.7 Score on scale
Standard Deviation 26.78
|
—
|
|
Quality of Life
[MTC Cycle 9 ]Fatigue Symptom Scale (n=33,50)
|
28.3 Score on scale
Standard Deviation 24.07
|
35.1 Score on scale
Standard Deviation 25.03
|
—
|
|
Quality of Life
[MTC Cycle 9 ]Nausea & Vomiting Symptom (n=33,50)
|
5.1 Score on scale
Standard Deviation 12.14
|
12.0 Score on scale
Standard Deviation 20.77
|
—
|
|
Quality of Life
[MTC Cycle 9 ]Pain Symptom Scale (n=33,50)
|
25.8 Score on scale
Standard Deviation 30.93
|
18.7 Score on scale
Standard Deviation 21.47
|
—
|
|
Quality of Life
[MTC Cycle 9 ]Insomnia Symptom Scale (n=33,49)
|
23.2 Score on scale
Standard Deviation 26.98
|
30.6 Score on scale
Standard Deviation 33.91
|
—
|
|
Quality of Life
[MTC Cycle 9 ]Appetite Loss Scale (n=33,50)
|
10.1 Score on scale
Standard Deviation 19.52
|
23.3 Score on scale
Standard Deviation 29.55
|
—
|
|
Quality of Life
[MTC Cycle 9 ]Constipation Symptom Scale (n=33,50)
|
13.1 Score on scale
Standard Deviation 24.92
|
16.0 Score on scale
Standard Deviation 25.41
|
—
|
|
Quality of Life
[MTC Cycle 9 ]Diarrhea Symptom Scale (n=33,50)
|
7.1 Score on scale
Standard Deviation 20
|
7.3 Score on scale
Standard Deviation 18.18
|
—
|
|
Quality of Life
[MTC Cycle 9]Financial Difficulties Scale n=33,50
|
15.2 Score on scale
Standard Deviation 23.70
|
22.0 Score on scale
Standard Deviation 27.45
|
—
|
|
Quality of Life
[MTC Cycle 11 ] Global Health Status Scale n=25,37
|
57.7 Score on scale
Standard Deviation 18.93
|
59.9 Score on scale
Standard Deviation 21.41
|
—
|
|
Quality of Life
[MTC Cycle 11 ]Physical Functional Scale (n=25,37)
|
79.2 Score on scale
Standard Deviation 16.48
|
81.1 Score on scale
Standard Deviation 17.81
|
—
|
|
Quality of Life
[MTC Cycle 11 ]Role Functional Scale (n=25,37)
|
77.3 Score on scale
Standard Deviation 18.56
|
73.9 Score on scale
Standard Deviation 27.37
|
—
|
|
Quality of Life
[MTC Cycle 11 ]Emotional Functional Scale n=25,37
|
78.3 Score on scale
Standard Deviation 19.09
|
80.0 Score on scale
Standard Deviation 19.88
|
—
|
|
Quality of Life
[MTC Cycle 11 ]Cognitive Functional Scale n=25,37
|
81.3 Score on scale
Standard Deviation 26.49
|
84.2 Score on scale
Standard Deviation 17.10
|
—
|
|
Quality of Life
[MTC Cycle 11 ]Social Functional Scale (n=25,37)
|
84.7 Score on scale
Standard Deviation 19.20
|
77.9 Score on scale
Standard Deviation 27.51
|
—
|
|
Quality of Life
[MTC Cycle 11 ]Fatigue Symptom Scale (n=25,37)
|
32.4 Score on scale
Standard Deviation 22.20
|
31.2 Score on scale
Standard Deviation 20.92
|
—
|
|
Quality of Life
[MTC Cycle 11 ]Nausea & Vomiting Scale (n=25,37)
|
6.7 Score on scale
Standard Deviation 15.96
|
9.5 Score on scale
Standard Deviation 18.23
|
—
|
|
Quality of Life
[MTC Cycle 11 ]Pain Symptom Scale (n=25,37)
|
29.3 Score on scale
Standard Deviation 28.98
|
19.8 Score on scale
Standard Deviation 27.45
|
—
|
|
Quality of Life
[MTC Cycle 11 ]Dyspnea Symptom Scale (n=25,37)
|
30.7 Score on scale
Standard Deviation 16.44
|
28.8 Score on scale
Standard Deviation 27.40
|
—
|
|
Quality of Life
[MTC Cycle 11 ]Insomnia Symptom Scale (n=25,37)
|
20.0 Score on scale
Standard Deviation 23.57
|
18.9 Score on scale
Standard Deviation 26.69
|
—
|
|
Quality of Life
[MTC Cycle 11 ]Appetite Loss Scale (n=25,37)
|
9.3 Score on scale
Standard Deviation 20.46
|
18 Score on scale
Standard Deviation 26.75
|
—
|
|
Quality of Life
MTC Cycle 11 ]Constipation Symptom Scale( n=25,37)
|
6.7 Score on scale
Standard Deviation 13.61
|
17.1 Score on scale
Standard Deviation 24.37
|
—
|
|
Quality of Life
[MTC Cycle 11 ]Diarrhea Symptom Scale ( n=25,37)
|
1.3 Score on scale
Standard Deviation 6.67
|
7.2 Score on scale
Standard Deviation 15.98
|
—
|
|
Quality of Life
[MTC Cycle 11]Financial Difficulties Scale n=24,37
|
15.3 Score on scale
Standard Deviation 25.97
|
18.0 Score on scale
Standard Deviation 26.75
|
—
|
|
Quality of Life
[EOS]Global Health Status Scale (n=123,127)
|
55.1 Score on scale
Standard Deviation 20.62
|
57.2 Score on scale
Standard Deviation 20.01
|
—
|
|
Quality of Life
[EOS]Physical Functional Scale (n=125,127)
|
70.2 Score on scale
Standard Deviation 23.49
|
72.5 Score on scale
Standard Deviation 22.06
|
—
|
|
Quality of Life
[EOS]Role Functional Scale (n=125,127)
|
63.5 Score on scale
Standard Deviation 32.43
|
64.3 Score on scale
Standard Deviation 29.68
|
—
|
|
Quality of Life
[EOS]Emotional Functional Scale (n=124,127)
|
74.4 Score on scale
Standard Deviation 21.36
|
77.3 Score on scale
Standard Deviation 20.20
|
—
|
|
Quality of Life
[EOS]Cognitive Functional Scale ( n=124,127)
|
79.3 Score on scale
Standard Deviation 24.91
|
83.5 Score on scale
Standard Deviation 19.30
|
—
|
|
Quality of Life
[EOS]Social Functional Scale (n=124,127)
|
73.3 Score on scale
Standard Deviation 29.28
|
72.6 Score on scale
Standard Deviation 27.90
|
—
|
|
Quality of Life
[EOS]Fatigue Symptom Scale (n=125,127)
|
41.0 Score on scale
Standard Deviation 26.42
|
37.6 Score on scale
Standard Deviation 23.80
|
—
|
|
Quality of Life
[EOS]Nausea & Vomiting Scale (n=125,127)
|
14.4 Score on scale
Standard Deviation 23.70
|
12.3 Score on scale
Standard Deviation 20.70
|
—
|
|
Quality of Life
[EOS]Pain Symptom Scale (n=125,127)
|
30.4 Score on scale
Standard Deviation 30.31
|
21.1 Score on scale
Standard Deviation 25.58
|
—
|
|
Quality of Life
[EOS]Dyspnea Symptom Scale (n=124,127)
|
31.5 Score on scale
Standard Deviation 29.85
|
34.1 Score on scale
Standard Deviation 29.83
|
—
|
|
Quality of Life
[EOS]Insomnia Symptom Scale( n=125,127)
|
27.2 Score on scale
Standard Deviation 26.57
|
22.6 Score on scale
Standard Deviation 28.45
|
—
|
|
Quality of Life
[EOS]Appetite Loss Symptom Scale (n=125,127)
|
26.9 Score on scale
Standard Deviation 31.31
|
26.0 Score on scale
Standard Deviation 30.26
|
—
|
|
Quality of Life
[EOS]Constipation Symptom Scale (n=125,127)
|
17.6 Score on scale
Standard Deviation 25.60
|
12.1 Score on scale
Standard Deviation 21.28
|
—
|
|
Quality of Life
[EOS]Diarrhea Symptom Scale(n=124,127)
|
9.7 Score on scale
Standard Deviation 20.72
|
6.8 Score on scale
Standard Deviation 15.34
|
—
|
|
Quality of Life
[EOS]Financial Difficulties Scale (n=123,126)
|
16.8 Score on scale
Standard Deviation 27.45
|
16.9 Score on scale
Standard Deviation 27.24
|
—
|
|
Quality of Life
[Pre-ind BL] Global Health Status Scale n=116,121
|
57.9 Score on scale
Standard Deviation 23.90
|
59.7 Score on scale
Standard Deviation 21.74
|
—
|
|
Quality of Life
[Pre-ind BL] Physical Functional Scale (n=118,121)
|
74.8 Score on scale
Standard Deviation 23.69
|
79.4 Score on scale
Standard Deviation 18.09
|
—
|
|
Quality of Life
[Pre-ind BL] Role Functional Scale (n=118,121)
|
68.4 Score on scale
Standard Deviation 32.50
|
71.1 Score on scale
Standard Deviation 28.28
|
—
|
|
Quality of Life
[Pre-ind BL] Emotional Functional Scale n=117,121
|
71.7 Score on scale
Standard Deviation 21.93
|
69.8 Score on scale
Standard Deviation 21.97
|
—
|
|
Quality of Life
[Pre-ind BL] Cognitive Functional Scale n=117,121
|
86.0 Score on scale
Standard Deviation 21.55
|
88.0 Score on scale
Standard Deviation 16.70
|
—
|
|
Quality of Life
[Pre-ind BL]] Social Functional Scale (n=116,120)
|
79.3 Score on scale
Standard Deviation 25.60
|
78.7 Score on scale
Standard Deviation 26.10
|
—
|
|
Quality of Life
[Pre-ind BL] Fatigue Symptom Scale (n=118,121)
|
33.3 Score on scale
Standard Deviation 27.18
|
31.5 Score on scale
Standard Deviation 21.73
|
—
|
|
Quality of Life
[Pre-ind BL] Nausea & Vomiting Scale n=118,121
|
7.2 Score on scale
Standard Deviation 17.50
|
4.3 Score on scale
Standard Deviation 12.46
|
—
|
|
Quality of Life
[Pre-ind BL] Pain Symptom Scale (n=118,121)
|
36.7 Score on scale
Standard Deviation 31.92
|
24.7 Score on scale
Standard Deviation 26.88
|
—
|
|
Quality of Life
[Pre-ind BL] Dyspnea Symptom Scale (n=118,121)
|
29.7 Score on scale
Standard Deviation 30.75
|
30.6 Score on scale
Standard Deviation 29.69
|
—
|
|
Quality of Life
[Pre-ind BL] Insomnia Symptom Scale n=118,121
|
33.3 Score on scale
Standard Deviation 34.59
|
33.9 Score on scale
Standard Deviation 30.42
|
—
|
|
Quality of Life
[Pre-ind BL] Appetite Loss Symptom Scale n=118,121
|
19.2 Score on scale
Standard Deviation 30.01
|
18.7 Score on scale
Standard Deviation 29.15
|
—
|
|
Quality of Life
[Pre-ind BL]] Constipation Symptom Scale n=118,121
|
18.6 Score on scale
Standard Deviation 30.68
|
9.1 Score on scale
Standard Deviation 20.18
|
—
|
|
Quality of Life
[Pre-ind BL] Diarrhea Symptom Scale (n=117,121)
|
7.1 Score on scale
Standard Deviation 17.96
|
5.2 Score on scale
Standard Deviation 14.91
|
—
|
|
Quality of Life
[Pre-ind BL]Financial Difficulties Scale n=114,120
|
17.3 Score on scale
Standard Deviation 30.48
|
17.2 Score on scale
Standard Deviation 29.62
|
—
|
|
Quality of Life
[MTC Cycle 3]Global Health Status (n=69,87)
|
63.3 Score on scale
Standard Deviation 20.02
|
58.6 Score on scale
Standard Deviation 19.71
|
—
|
|
Quality of Life
[MTC Cycle 3]Physical Functional Scale (n=69,87)
|
77.1 Score on scale
Standard Deviation 20.72
|
76.0 Score on scale
Standard Deviation 20.37
|
—
|
|
Quality of Life
[MTC Cycle 3]Role Functional Scale (n=69,87)
|
74.2 Score on scale
Standard Deviation 27.79
|
69.9 Score on scale
Standard Deviation 28.51
|
—
|
|
Quality of Life
[MTC Cycle 3]Emotional Functional Scale (n=69,87)
|
82.5 Score on scale
Standard Deviation 19.86
|
78.4 Score on scale
Standard Deviation 18.48
|
—
|
|
Quality of Life
[MTC Cycle 3]Cognitive Functional Scale (n=69,87)
|
84.3 Score on scale
Standard Deviation 23.20
|
82.6 Score on scale
Standard Deviation 19.17
|
—
|
|
Quality of Life
[MTC Cycle 3]Social Functional Scale (n=69,87)
|
82.1 Score on scale
Standard Deviation 25.62
|
73.0 Score on scale
Standard Deviation 24.28
|
—
|
|
Quality of Life
[MTC Cycle 3]Fatigue Symptom Scale (n=69,87)
|
32.1 Score on scale
Standard Deviation 22.88
|
34.5 Score on scale
Standard Deviation 21.50
|
—
|
|
Quality of Life
[MTC Cycle 3]Nausea and Vomiting Scale (n=69,87)
|
7.2 Score on scale
Standard Deviation 16.78
|
8.8 Score on scale
Standard Deviation 12.92
|
—
|
|
Quality of Life
[MTC Cycle 3]Pain Symptom Scale (n=69,87)
|
23.9 Score on scale
Standard Deviation 27.64
|
17.4 Score on scale
Standard Deviation 21.85
|
—
|
|
Quality of Life
[MTC Cycle 3]Dyspnea Symptom Scale (n=69,87)
|
26.1 Score on scale
Standard Deviation 27.93
|
29.9 Score on scale
Standard Deviation 26.91
|
—
|
Adverse Events
No Maintenance Treatment
Serious events: 70 serious events
Other events: 105 other events
Deaths: 0 deaths
Maintenance Treatment Arm A
Serious events: 26 serious events
Other events: 115 other events
Deaths: 0 deaths
Maintenance Treatment Arm B
Serious events: 42 serious events
Other events: 120 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
No Maintenance Treatment
n=128 participants at risk
A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm..
|
Maintenance Treatment Arm A
n=120 participants at risk
Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis
|
Maintenance Treatment Arm B
n=125 participants at risk
Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m\^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis..
|
|---|---|---|---|
|
Infections and infestations
Pneumonia
|
2.3%
3/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.6%
7/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Anal abscess
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Bronchitis
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Device related infection
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Sepsis
|
1.6%
2/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Abscess limb
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Clostridial infection
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Intervertebral discitis
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Lung infection
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Oesophageal candidiasis
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Post procedural infection
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Pulmonary sepsis
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Scrub typhus
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Septic shock
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Sinusitis
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
7.0%
9/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
2.5%
3/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.6%
2/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
2.3%
3/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Haemoptysis
|
1.6%
2/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.7%
2/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
1.6%
2/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopleural fistula
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Diarrhoea
|
1.6%
2/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.7%
2/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.6%
2/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.7%
2/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
2.4%
3/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Vomiting
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.7%
2/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Constipation
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Gastrointestinal toxicity
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Intestinal ischaemia
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Oesophageal perforation
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Tongue oedema
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
General physical health deterioration
|
2.3%
3/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Asthenia
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Death
|
1.6%
2/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Malaise
|
1.6%
2/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Pain
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Pyrexia
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Sudden death
|
1.6%
2/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Fatigue
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Haemorrhagic cyst
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Hyperthermia
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Impaired healing
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Mucosal inflammation
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Anaemia
|
3.1%
4/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Neutropenia
|
5.5%
7/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.6%
2/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Febrile bone marrow aplasia
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Dehydration
|
2.3%
3/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.3%
3/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.6%
2/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.6%
2/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.7%
2/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Vascular disorders
Thrombophlebitis
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Vascular disorders
Embolism arterial
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Vascular disorders
Embolism venous
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Vascular disorders
Hypertension
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Vascular disorders
Iliac artery embolism
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Vascular disorders
Ischaemia
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Vascular disorders
Peripheral ischaemia
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Vascular disorders
Thrombophlebitis superficial
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Vascular disorders
Vasculitis necrotising
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.6%
2/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Headache
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Nervous system disorder
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Presyncope
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Viith nerve paralysis
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Renal and urinary disorders
Renal failure
|
3.1%
4/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.6%
2/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Renal and urinary disorders
Renal failure acute
|
1.6%
2/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Renal and urinary disorders
Renal impairment
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Cardiac disorders
Myocardial infarction
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Cardiac disorders
Cardiac asthma
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Cardiac disorders
Cardiac failure
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Cardiac disorders
Cardiogenic shock
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Cardiac disorders
Cardiomyopathy
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Cardiac disorders
Pericardial effusion
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
General physical condition abnormal
|
1.6%
2/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
White blood cell count decreased
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Hepatobiliary disorders
Hepatic vein thrombosis
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Hepatobiliary disorders
Portal vein thrombosis
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Injury, poisoning and procedural complications
Respiratory fume inhalation disorder
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Psychiatric disorders
Confusional state
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Psychiatric disorders
Psychotic disorder
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Eye disorders
Vitreous detachment
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.80%
1/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
Other adverse events
| Measure |
No Maintenance Treatment
n=128 participants at risk
A total of 128 participants were not randomized to maintenance therapy because of discontinuations related to an AE, progressive disease, withdrawal of consent, or other reasons. Five participants in Bevacizumab Maintenance Trt Arm A and three in Bevacizumab +Pemetrexed Maintenance Trt Arm B, respectively, did not receive maintenance treatment so they were also included in the not randomized arm..
|
Maintenance Treatment Arm A
n=120 participants at risk
Bevacizumab 7.5 mg/kg was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 125 participants allocated to Bevacizumab Maintenance Trt Arm A, five participants did not receive treatment so they were excluded from analysis
|
Maintenance Treatment Arm B
n=125 participants at risk
Bevacizumab 7.5 mg/kg + pemetrexed 500mg/m\^2 was administered IV every 3 weeks until progression of disease, unacceptable toxicity, or withdrawal of consent. Among the 128 participants allocated to Bevacizumab +Pemetrexed Maintenance Trt Arm B, three participants did not receive treatment so they were excluded from analysis..
|
|---|---|---|---|
|
Gastrointestinal disorders
Nausea
|
36.7%
47/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
60.8%
73/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
61.6%
77/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Vomiting
|
16.4%
21/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
23.3%
28/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
26.4%
33/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Constipation
|
16.4%
21/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
27.5%
33/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
25.6%
32/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Diarrhoea
|
17.2%
22/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
13.3%
16/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
28.0%
35/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
6.2%
8/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.7%
8/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
8.8%
11/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Abdominal pain
|
3.1%
4/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
4.2%
5/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.4%
8/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Stomatitis
|
2.3%
3/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.0%
6/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.4%
8/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Gastrointestinal disorders
Dry mouth
|
1.6%
2/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.83%
1/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.6%
7/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Asthenia
|
19.5%
25/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
35.0%
42/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
24.8%
31/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Fatigue
|
17.2%
22/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
18.3%
22/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
32.0%
40/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Chest pain
|
8.6%
11/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
12.5%
15/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
12.0%
15/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Mucosal inflammation
|
9.4%
12/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.8%
7/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
12.0%
15/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Oedema peripheral
|
5.5%
7/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.3%
4/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
15.2%
19/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
General disorders
Pyrexia
|
6.2%
8/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.0%
6/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
12.8%
16/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
14.8%
19/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
22.5%
27/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
21.6%
27/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
13.3%
17/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
21.7%
26/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
19.2%
24/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.4%
12/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
17.5%
21/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
20.8%
26/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Dysphonia
|
3.9%
5/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.8%
7/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.4%
8/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.0%
6/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.2%
4/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
2.5%
3/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
7.2%
9/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Neutropenia
|
3.9%
5/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
21.7%
26/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
20.8%
26/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Anaemia
|
13.3%
17/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
16.7%
20/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
16.8%
21/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
3.1%
4/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.7%
8/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
2.4%
3/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Blood and lymphatic system disorders
Leukopenia
|
1.6%
2/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.0%
6/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.4%
8/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Vascular disorders
Hypertension
|
18.0%
23/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
35.8%
43/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
44.0%
55/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Headache
|
7.8%
10/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
15.8%
19/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
20.8%
26/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Dizziness
|
7.0%
9/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.8%
7/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
8.8%
11/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Paraesthesia
|
2.3%
3/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
3.3%
4/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
8.8%
11/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Dysgeusia
|
5.5%
7/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.0%
6/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.6%
7/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.6%
2/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
2.5%
3/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
7.2%
9/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
9.4%
12/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
9.2%
11/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
10.4%
13/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
11.7%
14/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
8.8%
11/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.1%
4/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
9.2%
11/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
8.8%
11/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
2.3%
3/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
4.2%
5/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
8.8%
11/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
9.2%
11/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.6%
2/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
18.8%
24/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
19.2%
23/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
25.6%
32/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.5%
7/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
1.7%
2/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.4%
8/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Weight decreased
|
12.5%
16/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.8%
7/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.4%
8/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Blood creatinine increased
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.0%
6/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
8.8%
11/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Haemoglobin decreased
|
5.5%
7/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
0.00%
0/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.6%
7/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
2.5%
3/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.6%
7/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Nasopharyngitis
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.7%
8/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
15.2%
19/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Bronchitis
|
0.78%
1/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.7%
8/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.6%
7/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Infections and infestations
Urinary tract infection
|
3.9%
5/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
2.5%
3/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.6%
7/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
6.2%
8/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
9.2%
11/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
16.0%
20/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.0%
6/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.6%
7/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Renal and urinary disorders
Proteinuria
|
3.1%
4/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
6.7%
8/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
8.0%
10/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Renal and urinary disorders
Renal impairment
|
2.3%
3/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.0%
6/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.6%
7/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Eye disorders
Lacrimation increased
|
3.1%
4/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
2.5%
3/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
12.8%
16/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Eye disorders
Conjunctivitis
|
0.00%
0/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.0%
6/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
4.0%
5/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Psychiatric disorders
Insomnia
|
3.1%
4/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
7.5%
9/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
7.2%
9/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
|
Cardiac disorders
Tachycardia
|
3.1%
4/128 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
5.0%
6/120 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
7.2%
9/125 • Up to 21 months (throughout the study)
Serious adverse events and non-serious adverse events are reported in Safety Analysis Set, which consists of all participants who received at least one dose of study medication and had a safety assessment performed post baseline.
|
Additional Information
Roche Trial Information Hotline
F. Hoffmann-La Roche AG
Phone: +41 616878333
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER