Trial Outcomes & Findings for Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma (NCT NCT01080391)
NCT ID: NCT01080391
Last Updated: 2022-09-21
Results Overview
Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). One or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
792 participants
Primary outcome timeframe
From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.
Results posted on
2022-09-21
Participant Flow
Participants were enrolled from 14 July 2010 to 15 March 2012. The primary analysis was conducted using a data cut-off date of 16 June 2014 and the final safety analysis after last subject last visit date (05 December 2017).
Eligible participants were randomized in a 1:1 ratio to one of two treatment groups. Randomization was stratified by β2 microglobulin level (\< vs. ≥ 2.5 mg/L), prior bortezomib exposure (no vs. yes), and prior lenalidomide exposure (no vs. yes).
Participant milestones
| Measure |
Lenalidomide and Dexamethasone (Rd)
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
|
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
|
|---|---|---|
|
Overall Study
STARTED
|
396
|
396
|
|
Overall Study
Treated
|
389
|
392
|
|
Overall Study
COMPLETED
|
389
|
392
|
|
Overall Study
NOT COMPLETED
|
7
|
4
|
Reasons for withdrawal
| Measure |
Lenalidomide and Dexamethasone (Rd)
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
|
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
|
|---|---|---|
|
Overall Study
Randomized but not treated
|
7
|
4
|
Baseline Characteristics
Study Comparing Carfilzomib, Lenalidomide, and Dexamethasone (CRd) vs Lenalidomide and Dexamethasone (Rd) in Subjects With Relapsed Multiple Myeloma
Baseline characteristics by cohort
| Measure |
Lenalidomide and Dexamethasone (Rd)
n=396 Participants
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
|
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
n=396 Participants
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
|
Total
n=792 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
64.5 years
STANDARD_DEVIATION 9.04 • n=5 Participants
|
63.3 years
STANDARD_DEVIATION 9.21 • n=7 Participants
|
63.9 years
STANDARD_DEVIATION 9.14 • n=5 Participants
|
|
Sex: Female, Male
Female
|
164 Participants
n=5 Participants
|
181 Participants
n=7 Participants
|
345 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
232 Participants
n=5 Participants
|
215 Participants
n=7 Participants
|
447 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Native Hawaiian or Pacific Islander
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
11 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
377 Participants
n=5 Participants
|
377 Participants
n=7 Participants
|
754 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Serum β2 Microglobulin
< 2.5 mg/L
|
77 Participants
n=5 Participants
|
77 Participants
n=7 Participants
|
154 Participants
n=5 Participants
|
|
Serum β2 Microglobulin
≥ 2.5 mg/L
|
319 Participants
n=5 Participants
|
319 Participants
n=7 Participants
|
638 Participants
n=5 Participants
|
|
Prior Bortezomib Exposure
Yes
|
261 Participants
n=5 Participants
|
261 Participants
n=7 Participants
|
522 Participants
n=5 Participants
|
|
Prior Bortezomib Exposure
No
|
135 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
270 Participants
n=5 Participants
|
|
Prior Lenalidomide Exposure
Yes
|
78 Participants
n=5 Participants
|
80 Participants
n=7 Participants
|
158 Participants
n=5 Participants
|
|
Prior Lenalidomide Exposure
No
|
318 Participants
n=5 Participants
|
316 Participants
n=7 Participants
|
634 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.Population: ITT analysis set comprised of all randomized participants
Kaplan-Meier estimate of median time from randomization to progressive disease (PD) or all-cause death. PD was assessed using International Myeloma Working Group-Uniform Response Criteria (IMWG-URC). One or more conditions were required to meet PD: 2 consecutive rising serum or urine M-protein from central lab; documented new bone lesion(s) or soft tissue plasmacytoma(s) or increased size of existing bone lesion(s) or plasmacytoma(s); or confirmed hypercalcemia due solely to plasma cell proliferative disorder (local lab greater than 11.5 mg/dL on 2 separate occasions). Censoring conditions (censoring dates) were: no post-baseline disease assessment (DA) (randomization date); started non-protocol systemic anticancer treatment before PD or death (last DA date before such treatment); died or had PD after more than 1 missed DA (last DA date without PD before the first missed visit); or were alive and without documentation of PD, including lost to follow-up without PD (last DA date).
Outcome measures
| Measure |
Lenalidomide and Dexamethasone (Rd)
n=396 Participants
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
|
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
n=396 Participants
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
|
|---|---|---|
|
Progression-free Survival (PFS)
|
17.6 months
Interval 15.0 to 20.6
|
26.3 months
Interval 23.3 to 30.5
|
SECONDARY outcome
Timeframe: From randomization through the data cutoff date of 28 April 2017 for the final analysis of overall survival; median follow up time was 67.1 months in each treatment group.Population: ITT analysis set comprised of all randomized participants
Overall survival (OS) was defined as the duration from randomization to death due to any cause. Participants who were still alive were censored at the date when the participant was last known to be alive or the data cutoff date, whichever occurred earlier.
Outcome measures
| Measure |
Lenalidomide and Dexamethasone (Rd)
n=396 Participants
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
|
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
n=396 Participants
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
|
|---|---|---|
|
Overall Survival
|
40.4 months
Interval 33.6 to 44.4
|
48.3 months
Interval 42.4 to 52.8
|
SECONDARY outcome
Timeframe: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.Population: ITT analysis set comprised of all randomized participants
Overall response rate is defined as the percentage of participants who achieved either a confirmed stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR) as their best response based on the Independent Review Committee (IRC) assessed response outcome. Response was determined using the International Myeloma Working Group - Uniform Response Criteria (IMWG-URC).
Outcome measures
| Measure |
Lenalidomide and Dexamethasone (Rd)
n=396 Participants
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
|
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
n=396 Participants
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
|
|---|---|---|
|
Overall Response Rate
|
66.7 percentage of participants
Interval 61.8 to 71.3
|
87.1 percentage of participants
Interval 83.4 to 90.3
|
SECONDARY outcome
Timeframe: From randomization through the data cutoff date of 16 June 2014. Median follow-up time was approximately 31 months.Population: ITT analysis set comprised of all randomized participants
Disease control rate was defined as the percentage of participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), partial response (PR), minimal response (MR), or stable disease (SD) lasting ≥ 8 weeks according to International Myeloma Working Group - Uniform Response Criteria (IMWG-URC) (MR was determined using European Group for Blood and Marrow Transplantation criteria).
Outcome measures
| Measure |
Lenalidomide and Dexamethasone (Rd)
n=396 Participants
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
|
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
n=396 Participants
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
|
|---|---|---|
|
Disease Control Rate
|
87.1 percentage of participants
Interval 83.4 to 90.3
|
92.7 percentage of participants
Interval 89.7 to 95.0
|
SECONDARY outcome
Timeframe: From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 42 months.Population: The Intent to treat (ITT) population with participantant who achieved a best overall response of PR or better.
Duration of response (DOR) was calculated for participants who achieved a best response of stringent complete response (sCR), complete response (CR), very good partial response (VGPR), or partial response (PR). Duration of response was defined as the time in months from the initial start of response (PR or better) to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
Outcome measures
| Measure |
Lenalidomide and Dexamethasone (Rd)
n=264 Participants
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
|
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
n=345 Participants
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
|
|---|---|---|
|
Duration of Response
|
21.2 months
Interval 16.7 to 25.8
|
28.6 months
Interval 24.9 to 31.3
|
SECONDARY outcome
Timeframe: From randomization through the data cutoff date of 16 June 2014. Longest follow-up time was approximately 46 months.Population: The Intent to treat (ITT) population with participantants who achieved disease control.
Duration of disease control (DDC) was calculated for participants who achieved disease control. DDC was defined as the time in months from randomization to the earlier of documented progressive disease (PD) or death due to any cause. Participants who had not progressed or died were censored according to the censoring rules defined previously for PFS.
Outcome measures
| Measure |
Lenalidomide and Dexamethasone (Rd)
n=345 Participants
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
|
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
n=367 Participants
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
|
|---|---|---|
|
Duration of Disease Control
|
18.9 months
Interval 16.6 to 22.2
|
28.7 months
Interval 24.4 to 31.6
|
SECONDARY outcome
Timeframe: Cycle 1 Day 1 (Baseline), Day 1 of Cycles 3, 6, 12, 18Population: ITT analysis set participants with a baseline value.
Health-related quality of life was assessed with the use of the European Organization for Research and Treatment of Cancer Quality of Life Core Module (QLQ-C30) questionnaire, a validated instrument in multiple myeloma patients. Scores range from 0 to 100, with higher scores indicating better health related quality of life.
Outcome measures
| Measure |
Lenalidomide and Dexamethasone (Rd)
n=367 Participants
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
|
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
n=375 Participants
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
|
|---|---|---|
|
Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores
Cycle 1 Day 1 (Baseline)
|
58.1 scores on a scale
Standard Deviation 21.7
|
58.3 scores on a scale
Standard Deviation 21.7
|
|
Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores
Cycle 3, Day 1
|
56.8 scores on a scale
Standard Deviation 19.4
|
59.9 scores on a scale
Standard Deviation 20.4
|
|
Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores
Cycle 6, Day 1
|
58.9 scores on a scale
Standard Deviation 19.7
|
62.5 scores on a scale
Standard Deviation 20.1
|
|
Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores
Cycle 12, Day 1
|
57.3 scores on a scale
Standard Deviation 19.7
|
62.7 scores on a scale
Standard Deviation 19.6
|
|
Quality of Life Core Module (QLQ-C30) Global Health Status/Quality of Life Scores
Cycle 18, Day 1
|
59.9 scores on a scale
Standard Deviation 18.8
|
64.3 scores on a scale
Standard Deviation 19.2
|
Adverse Events
Lenalidomide and Dexamethasone (Rd)
Serious events: 221 serious events
Other events: 358 other events
Deaths: 0 deaths
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
Serious events: 256 serious events
Other events: 370 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lenalidomide and Dexamethasone (Rd)
n=389 participants at risk
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
|
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
n=392 participants at risk
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
|
|---|---|---|
|
Eye disorders
Cataract subcapsular
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Retinal vein occlusion
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal hernia obstructive
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.77%
3/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
4/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Ear and labyrinth disorders
Vertigo
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Adrenal insufficiency
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Endocrine disorders
Hypothyroidism
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Cataract
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
5/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Cataract nuclear
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Anaemia
|
2.6%
10/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
8/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Bone marrow failure
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.0%
4/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
8/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Haemolytic anaemia
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Leukopenia
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Neutropenia
|
1.3%
5/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
4/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Pancytopenia
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Platelet disorder
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
1.0%
4/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
5/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
5/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina pectoris
|
1.0%
4/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Angina unstable
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Arrhythmia
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial fibrillation
|
2.1%
8/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.3%
9/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial flutter
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrial tachycardia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Atrioventricular block complete
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Bradycardia
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac arrest
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure
|
0.77%
3/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
5/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.77%
3/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
5/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiopulmonary failure
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery occlusion
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Coronary artery stenosis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Left ventricular dysfunction
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Mitral valve incompetence
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial infarction
|
0.77%
3/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
6/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Myocardial ischaemia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Pericardial effusion
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Stress cardiomyopathy
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Tachycardia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Colitis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dental caries
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
2.3%
9/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
7/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diverticular perforation
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diverticulum oesophageal
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Enteritis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Ileus
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Impaired gastric emptying
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Lower gastrointestinal haemorrhage
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Neutropenic colitis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest pain
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Death
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Disease progression
|
2.1%
8/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
5/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
General physical health deterioration
|
1.0%
4/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Influenza like illness
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Malaise
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Mucosal inflammation
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Multi-organ failure
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.77%
3/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
3.1%
12/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.8%
15/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Sudden death
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Bile duct stone
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholangitis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.77%
3/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
4/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatitis toxic
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Cytokine release syndrome
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Immune system disorders
Drug hypersensitivity
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bacteraemia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bacterial infection
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchiolitis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
2.8%
11/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.3%
9/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis viral
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchopneumonia
|
1.8%
7/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
5/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchopulmonary aspergillosis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Catheter site cellulitis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
1.0%
4/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cholangitis suppurative
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Chronic hepatitis C
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Clostridial infection
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
4/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cystitis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Device related infection
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.77%
3/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Diverticulitis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Endocarditis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Enterocolitis bacterial
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Erysipelas
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Escherichia sepsis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Escherichia urinary tract infection
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis
|
1.3%
5/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
5/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Genitourinary tract infection
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gingivitis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Hepatic infection
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Herpes zoster disseminated
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Incision site infection
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Infection
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Influenza
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.77%
3/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Laryngitis bacterial
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Listeria sepsis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Liver abscess
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lobar pneumonia
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.77%
3/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lower respiratory tract infection viral
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Lung infection
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.77%
3/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Neutropenic sepsis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Peritonitis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumocystis jiroveci pneumonia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
13.4%
52/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
17.1%
67/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia bacterial
|
0.77%
3/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia influenzal
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia respiratory syncytial viral
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia viral
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Postoperative abscess
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pulmonary sepsis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pyelonephritis acute
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Respiratory syncytial virus bronchiolitis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Respiratory syncytial virus infection
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Respiratory tract infection
|
2.1%
8/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
4.1%
16/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Salmonella sepsis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis
|
1.3%
5/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.8%
7/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis syndrome
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Septic shock
|
1.0%
4/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.77%
3/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sinusitis
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
4/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Staphylococcal bacteraemia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Streptococcal bacteraemia
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Testicular abscess
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tonsillitis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tooth abscess
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tracheobronchitis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Tuberculosis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
4/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
4/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urosepsis
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fall
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Femoral neck fracture
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Femur fracture
|
0.77%
3/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
5/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Gallbladder injury
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.77%
3/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Jaw fracture
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Joint dislocation
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Multiple fractures
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Road traffic accident
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Spinal compression fracture
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Splenic injury
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Stress fracture
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Traumatic fracture
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatinine increased
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Cardiac stress test abnormal
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
General physical condition abnormal
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Influenza A virus test positive
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Intraocular pressure increased
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Monoclonal immunoglobulin present
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Respiratory syncytial virus test positive
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Streptococcus test positive
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Viral test positive
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Weight decreased
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Electrolyte imbalance
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Fluid overload
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Gout
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.77%
3/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.77%
3/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Mineral deficiency
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Tumour lysis syndrome
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.77%
3/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Type 2 diabetes mellitus
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
1.0%
4/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Chondrocalcinosis pyrophosphate
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Fracture pain
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Gouty arthritis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc compression
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Joint swelling
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteoarthritis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Osteonecrosis of jaw
|
0.77%
3/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pathological fracture
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Rotator cuff syndrome
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spinal column stenosis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Tenosynovitis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma pancreas
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
1.0%
4/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.3%
5/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colorectal cancer
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal neoplasm
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastrointestinal stromal tumour
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic neoplasm malignant
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leukaemia plasmacytic
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant neoplasm of pleura
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Multiple myeloma
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Myelodysplastic syndrome
|
1.0%
4/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-small cell lung cancer
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic carcinoma metastatic
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pancreatic neoplasm
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasmacytoma
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal cancer
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
0.77%
3/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Altered state of consciousness
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Amyotrophic lateral sclerosis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cauda equina syndrome
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral cyst
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral haemorrhage
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebrovascular accident
|
2.6%
10/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
4/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cognitive disorder
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Coma
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Convulsion
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Haemorrhage intracranial
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hydrocephalus
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Loss of consciousness
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Myxoedema coma
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neuralgia
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraparesis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Polyneuropathy
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Spinal cord compression
|
0.77%
3/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Syncope
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.77%
3/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.77%
3/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
VIth nerve paralysis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Confusional state
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Disorientation
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Mental status changes
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Personality change
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Psychiatric decompensation
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Nephropathy
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Nephrotic syndrome
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Prerenal failure
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure acute
|
1.0%
4/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.5%
6/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal failure chronic
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Renal impairment
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urinary retention
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Reproductive system and breast disorders
Epididymitis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
4/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Alveolitis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis chronic
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchopneumopathy
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.77%
3/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.77%
3/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
4/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Eosinophilic pneumonia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Lung disorder
|
1.0%
4/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural fibrosis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
2.1%
8/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.1%
12/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary oedema
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
4/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.0%
4/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Acute generalised exanthematous pustulosis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
1.0%
4/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Aortic aneurysm
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Circulatory collapse
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis
|
1.5%
6/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.3%
9/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Embolism
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Haematoma
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypotension
|
0.77%
3/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Orthostatic hypotension
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Thrombosis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.77%
3/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Vasculitis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Venous thrombosis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Aortic valve stenosis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Bradyarrhythmia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac asthma
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Duodenal ulcer
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Umbilical hernia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Drowning
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Arthritis infective
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Atypical pneumonia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cholangitis infective
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Clostridium difficile infection
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.51%
2/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Epididymitis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Gastroenteritis salmonella
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Hepatitis B
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Osteomyelitis
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Osteomyelitis bacterial
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Progressive multifocal leukoencephalopathy
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Staphylococcal infection
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Staphylococcal sepsis
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Stoma site abscess
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Facial bones fracture
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Humerus fracture
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Pubis fracture
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Crystal arthropathy
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Spinal pain
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
B precursor type acute leukaemia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Glioblastoma
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatic cancer
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Laryngeal cancer
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung adenocarcinoma
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Non-Hodgkin's lymphoma
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell leukaemia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Plasma cell myeloma
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Guillain-Barre syndrome
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Ischaemic cerebral infarction
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Ischaemic stroke
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Seizure
|
0.51%
2/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Acute kidney injury
|
1.0%
4/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
2.0%
8/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Chronic kidney disease
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Renal and urinary disorders
Urethral prolapse
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Laryngospasm
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive airways disorder
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Peripheral ischaemia
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Venous thrombosis limb
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Left ventricular failure
|
0.26%
1/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.00%
0/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
0.26%
1/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Lenalidomide and Dexamethasone (Rd)
n=389 participants at risk
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Lenalidomide 25 mg was administered orally on days 1 to 21 and dexamethasone 40 mg was administered orally or intravenously on days 1, 8, 15, and 22.
|
Carfilzomib, Lenalidomide, and Dexamethasone (CRd)
n=392 participants at risk
Participants received their randomized study treatment in 28-day cycles until disease progression or unacceptable toxicity. Carfilzomib 20 mg/m² was administered intravenously (IV) on days 1 and 2 of cycle 1, then escalated to 27 mg/m² on Days 8, 9, 15, and 16 of cycle 1 and continuing on days 1, 2, 8, 9, 15, and 16 of cycle 2 through cycle 12 and then from cycle 13 through cycle 18, 27 mg/m² on days 1, 2, 15, and 16. Lenalidomide 25 mg was administered orally on days 1 to 21 of every cycle. Dexamethasone 40 mg was administered orally or IV on days 1, 8, 15, and 22 of every cycle.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
20.8%
81/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
18.6%
73/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.3%
36/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.9%
39/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
21.1%
82/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
27.0%
106/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Anaemia
|
39.6%
154/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
42.3%
166/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Leukopenia
|
5.7%
22/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.4%
33/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Neutropenia
|
34.2%
133/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
40.1%
157/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
24.2%
94/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
29.3%
115/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Cataract
|
9.3%
36/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.9%
39/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Eye disorders
Vision blurred
|
3.9%
15/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.1%
24/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain
|
6.9%
27/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.2%
32/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
3.1%
12/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
28/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Constipation
|
17.7%
69/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.7%
81/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
36.8%
143/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
43.4%
170/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
22/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.1%
24/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
14.7%
57/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.9%
82/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
8.7%
34/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.5%
49/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
14.7%
57/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
18.4%
72/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chills
|
2.3%
9/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.6%
26/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
31.9%
124/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
33.7%
132/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Oedema peripheral
|
17.0%
66/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
19.9%
78/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
20.6%
80/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
28.1%
110/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Bronchitis
|
14.4%
56/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
19.1%
75/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Influenza
|
3.6%
14/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.6%
26/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
16.7%
65/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
22.2%
87/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
7.5%
29/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
11.5%
45/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Respiratory tract infection
|
10.0%
39/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.5%
41/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sinusitis
|
4.6%
18/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.1%
24/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Upper respiratory tract infection
|
20.8%
81/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
29.3%
115/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Urinary tract infection
|
5.4%
21/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
9.2%
36/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral infection
|
2.8%
11/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
28/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Alanine aminotransferase increased
|
3.9%
15/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
21/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Blood creatinine increased
|
5.4%
21/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.9%
27/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Neutrophil count decreased
|
5.7%
22/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
21/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
9.0%
35/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.0%
47/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
10.0%
39/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.2%
48/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypocalcaemia
|
12.6%
49/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
16.6%
65/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
14.9%
58/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
29.1%
114/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypomagnesaemia
|
7.5%
29/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
10.2%
40/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hypophosphataemia
|
8.5%
33/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.5%
57/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
14.7%
57/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.5%
57/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
6.2%
24/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
28/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
7.5%
29/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.6%
26/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
9.3%
36/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.4%
25/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
5.7%
22/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.4%
25/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.8%
42/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.2%
48/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
11.6%
45/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
13.8%
54/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dysgeusia
|
5.4%
21/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
14/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
8.2%
32/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
14.3%
56/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Neuropathy peripheral
|
7.2%
28/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.7%
34/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraesthesia
|
5.9%
23/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.9%
27/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
6.9%
27/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.4%
25/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Tremor
|
8.2%
32/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
28/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anxiety
|
4.4%
17/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
8.4%
33/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Insomnia
|
16.7%
65/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.7%
81/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.0%
70/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
29.6%
116/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
15.2%
59/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
19.4%
76/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
4.9%
19/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.9%
23/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.7%
22/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
28/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
3.3%
13/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.7%
30/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
4.6%
18/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.1%
28/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.1%
16/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
7.9%
31/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash
|
15.2%
59/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
12.8%
50/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis
|
2.8%
11/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
21/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
7.7%
30/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
15.8%
62/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypotension
|
5.7%
22/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
6.6%
26/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Toothache
|
3.1%
12/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
20/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Peripheral swelling
|
5.4%
21/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
21/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
17.5%
68/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
20.4%
80/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Weight decreased
|
5.1%
20/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
3.6%
14/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Hyperuricaemia
|
2.8%
11/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.6%
22/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.4%
17/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.1%
20/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
3.1%
12/389 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
5.4%
21/392 • From the first dose of study drug to 30 days after the last dose or initiation of new anticancer therapy, whichever occurred first. Median treatment duration was 57 and 88 weeks in each treatment group respectively, with a maximum of 338 weeks.
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER