Trial Outcomes & Findings for Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer (NCT NCT02923921)
NCT ID: NCT02923921
Last Updated: 2020-10-19
Results Overview
Overall survival is defined as the time from date of randomization to the date of death (due to any cause). For participants whose last known status is alive at the data cutoff date for the analysis, time will be censored as the last contact date prior to the data cutoff date.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
567 participants
Primary outcome timeframe
Randomization to date of death from any cause (Up To 30 Months)
Results posted on
2020-10-19
Participant Flow
In the Participant Flow, participants who completed were those who died due to any cause or were alive and on study at conclusion but off treatment.
Participant milestones
| Measure |
Pegilodecakin + FOLFOX
Pegilodecakin 5 microgram per kilogram (μg/kg) dosed as one of the following 2 fixed doses: 0.4 milligram (mg) for participants weighing less than or equal to (≤) 80 kg or 0.8 mg for participants weighing greater than (\>) 80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX \[dl-Leucovorin (dl-LV) 400 milligram per meter square (mg/m2) and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2\] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression \[that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity\], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing\>80 kg.
|
FOLFOX
FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
|
|---|---|---|
|
Overall Study
STARTED
|
283
|
284
|
|
Overall Study
Received at Least 1 Dose of Study Drug
|
278
|
251
|
|
Overall Study
Safety Population
|
278
|
251
|
|
Overall Study
COMPLETED
|
230
|
227
|
|
Overall Study
NOT COMPLETED
|
53
|
57
|
Reasons for withdrawal
| Measure |
Pegilodecakin + FOLFOX
Pegilodecakin 5 microgram per kilogram (μg/kg) dosed as one of the following 2 fixed doses: 0.4 milligram (mg) for participants weighing less than or equal to (≤) 80 kg or 0.8 mg for participants weighing greater than (\>) 80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX \[dl-Leucovorin (dl-LV) 400 milligram per meter square (mg/m2) and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2\] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression \[that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity\], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing\>80 kg.
|
FOLFOX
FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
|
|---|---|---|
|
Overall Study
Sponsor Decision
|
39
|
38
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
6
|
13
|
|
Overall Study
Unknown, Not Collected
|
7
|
6
|
Baseline Characteristics
Study of Pegilodecakin (LY3500518) With FOLFOX Compared to FOLFOX Alone Second-line Tx in Participants With Metastatic Pancreatic Cancer
Baseline characteristics by cohort
| Measure |
Pegilodecakin + FOLFOX
n=283 Participants
Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing\>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX \[dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2\] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression \[that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity\], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing\>80 kg.
|
FOLFOX
n=284 Participants
FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
|
Total
n=567 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.8 years
STANDARD_DEVIATION 9.0 • n=99 Participants
|
64.1 years
STANDARD_DEVIATION 9.9 • n=107 Participants
|
64.0 years
STANDARD_DEVIATION 9.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
135 Participants
n=99 Participants
|
132 Participants
n=107 Participants
|
267 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
148 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
300 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
263 Participants
n=99 Participants
|
265 Participants
n=107 Participants
|
528 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
59 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
114 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
207 Participants
n=99 Participants
|
213 Participants
n=107 Participants
|
420 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
93 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
182 Participants
n=206 Participants
|
|
Region of Enrollment
United Kingdom
|
5 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
Spain
|
42 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
73 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
2 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Region of Enrollment
South Korea
|
48 Participants
n=99 Participants
|
41 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
3 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
Belgium
|
17 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
36 Participants
n=206 Participants
|
|
Region of Enrollment
Taiwan
|
5 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
15 Participants
n=206 Participants
|
|
Region of Enrollment
Poland
|
8 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
28 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
67 Participants
n=206 Participants
|
|
Region of Enrollment
France
|
9 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
14 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Region of Enrollment
Germany
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Randomization to date of death from any cause (Up To 30 Months)Population: All randomized participants. The number of participants censored were Pegilodecakin + FOLFOX = 63 and FOLFOX = 73.
Overall survival is defined as the time from date of randomization to the date of death (due to any cause). For participants whose last known status is alive at the data cutoff date for the analysis, time will be censored as the last contact date prior to the data cutoff date.
Outcome measures
| Measure |
FOLFOX
n=284 Participants
FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
|
Pegilodecakin + FOLFOX
n=283 Participants
Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing\>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX \[dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2\] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression \[that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity\], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing\>80 kg.
|
|---|---|---|
|
Overall Survival
|
6.28 Months
Interval 5.62 to 7.39
|
5.78 Months
Interval 5.45 to 6.64
|
SECONDARY outcome
Timeframe: Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)Population: All randomized participants. The number of participants censored were Pegilodecakin + FOLFOX = 45 and FOLFOX = 86.
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant did not have a complete baseline disease assessment, then PFS was censored at the enrollment date, regardless whether or not objectively determined PD or death had been observed for the participant.
Outcome measures
| Measure |
FOLFOX
n=284 Participants
FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
|
Pegilodecakin + FOLFOX
n=283 Participants
Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing\>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX \[dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2\] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression \[that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity\], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing\>80 kg.
|
|---|---|---|
|
Progression Free Survival
|
2.10 Months
Interval 1.94 to 3.25
|
2.14 Months
Interval 1.94 to 3.38
|
SECONDARY outcome
Timeframe: Randomization to PD (Up To 30 Months)Population: All randomized participants.
ORR was the percentage of participants achieving a best overall response (BOR) of complete response (CR) or partial response (PR) as per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the longest diameters (LD) of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. Participants who discontinued study treatment (for reasons other than progression) before entering concurrent phase were considered to have non-evaluable response.
Outcome measures
| Measure |
FOLFOX
n=284 Participants
FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
|
Pegilodecakin + FOLFOX
n=283 Participants
Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing\>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX \[dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2\] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression \[that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity\], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing\>80 kg.
|
|---|---|---|
|
Percentage of Participants Achieving Complete Response (CR) or Partial Response (PR) [Objective Response Rate (ORR)] That Assessed by Investigator
|
5.6 Percentage of participants
|
4.6 Percentage of participants
|
SECONDARY outcome
Timeframe: Randomization to Objective Progressive Disease or Start of New Anti-Cancer Therapy (Up To 30 Months)Population: All randomized participants.
Disease Control Rate (DCR) was the percentage of participants with a best overall response of CR, PR, or Stable Disease (SD) as per Response using RECIST v1.1 criteria. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. SD was neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD for target lesions, no progression of non-target lesions, and no appearance of new lesions. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Outcome measures
| Measure |
FOLFOX
n=284 Participants
FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
|
Pegilodecakin + FOLFOX
n=283 Participants
Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing\>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX \[dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2\] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression \[that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity\], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing\>80 kg.
|
|---|---|---|
|
Percentage of Participants With a Best Overall Response of Complete Response (CR), Partial Response (PR) or Stable Disease (SD): Disease Control Rate (DCR)
|
36.6 Percentage of participants
|
42.8 Percentage of participants
|
SECONDARY outcome
Timeframe: Randomization to Progressive Disease (PD) or Date of Death (Up To 30 Months)Population: All randomized participants who achieved an objective response of CR or PR. The number of participants censored were Pegilodecakin + FOLFOX = 4 and FOLFOX = 7.
DOR was the time from the date of first evidence of complete response or partial response to the date of objective progression or the date of death due to any cause, whichever is earlier. CR and PR were defined using the RECIST v1.1. CR defined as the disappearance of all target and non-target lesions and no appearance of new lesions. PR defined as at least a 30% decrease in the sum of the LD of target lesions (taking as reference the baseline sum LD), no progression of non-target lesions, and no appearance of new lesions. If a responder was not known to have died or have objective progression as of the data inclusion cutoff date, duration of response was censored at the last adequate tumor assessment date. PD was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions.
Outcome measures
| Measure |
FOLFOX
n=16 Participants
FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
|
Pegilodecakin + FOLFOX
n=13 Participants
Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing\>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX \[dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2\] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression \[that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity\], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing\>80 kg.
|
|---|---|---|
|
Duration of Response (DOR)
|
5.17 Months
Interval 3.75 to 5.72
|
4.99 Months
Interval 3.45 to 7.06
|
SECONDARY outcome
Timeframe: From randomization to until the date of first documented date of death from any cause within 12 monthsPopulation: All randomized participants.
The 12-month survival rate is defined as the percentage of participants who have not died 12 months after the date of randomization.
Outcome measures
| Measure |
FOLFOX
n=284 Participants
FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
|
Pegilodecakin + FOLFOX
n=283 Participants
Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing\>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX \[dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2\] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression \[that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity\], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing\>80 kg.
|
|---|---|---|
|
Percentage of Participants Alive at 1 Year (12-Month Survival Rate)
|
19.1 Percentage of participants
Interval 14.1 to 24.7
|
14.7 Percentage of participants
Interval 10.2 to 19.9
|
Adverse Events
Pegilodecakin + FOLFOX
Serious events: 123 serious events
Other events: 271 other events
Deaths: 217 deaths
FOLFOX
Serious events: 95 serious events
Other events: 240 other events
Deaths: 188 deaths
Serious adverse events
| Measure |
Pegilodecakin + FOLFOX
n=278 participants at risk
Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing\>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX \[dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2\] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression \[that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity\], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing\>80 kg.
|
FOLFOX
n=251 participants at risk
FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
|
|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
1.1%
3/278 • Number of events 5 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
1.1%
3/278 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Neutropenia
|
0.72%
2/278 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
3/251 • Number of events 4 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Acute myocardial infarction
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Angina pectoris
|
0.72%
2/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.80%
2/251 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac arrest
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Cardiac disorders
Cardiac failure acute
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
1.1%
3/278 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
4.0%
11/278 • Number of events 14 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
3/251 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Ascites
|
0.72%
2/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Colitis
|
0.72%
2/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
0.72%
2/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.72%
2/278 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
5/251 • Number of events 5 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Duodenal obstruction
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Duodenal stenosis
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Duodenal ulcer haemorrhage
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastric haemorrhage
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastritis
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastroduodenal ulcer
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal haemorrhage
|
0.72%
2/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Gastrointestinal stenosis
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.80%
2/251 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Ileal perforation
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Intestinal obstruction
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
3/251 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Large intestinal obstruction
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
1.1%
3/278 • Number of events 4 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Obstruction gastric
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Oesophageal stenosis
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal haemorrhage
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Small intestinal obstruction
|
1.1%
3/278 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.80%
2/251 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Upper gastrointestinal haemorrhage
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
2.5%
7/278 • Number of events 8 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.0%
5/251 • Number of events 5 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Asthenia
|
0.72%
2/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Euthanasia
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Fatigue
|
0.36%
1/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.80%
2/251 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
General physical health deterioration
|
1.1%
3/278 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.80%
2/251 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Generalised oedema
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Hyperpyrexia
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Malaise
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Mucosal inflammation
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Multiple organ dysfunction syndrome
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
4.7%
13/278 • Number of events 15 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
2.8%
7/251 • Number of events 7 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Bile duct obstruction
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Bile duct stenosis
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholangitis
|
2.2%
6/278 • Number of events 8 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.80%
2/251 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholangitis acute
|
0.72%
2/278 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic cirrhosis
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic function abnormal
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Hepatic pain
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Hepatobiliary disorders
Jaundice cholestatic
|
1.1%
3/278 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
3/251 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Immune system disorders
Anaphylactic reaction
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Abdominal sepsis
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bacteraemia
|
1.1%
3/278 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Bacterial disease carrier
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Biliary sepsis
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.80%
2/251 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Biliary tract infection
|
1.1%
3/278 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 4 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cellulitis
|
0.36%
1/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Cholangitis infective
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Clostridium difficile colitis
|
0.72%
2/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Device related infection
|
1.4%
4/278 • Number of events 5 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Device related sepsis
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Enterobacter sepsis
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Enterocolitis infectious
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Escherichia sepsis
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Gastroenteritis norovirus
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Klebsiella sepsis
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Liver abscess
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Peritonsillar abscess
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumococcal sepsis
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumocystis jirovecii pneumonia
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia
|
2.5%
7/278 • Number of events 8 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
4/251 • Number of events 4 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Pneumonia cryptococcal
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Respiratory tract infection
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Sepsis
|
3.6%
10/278 • Number of events 10 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
4/251 • Number of events 4 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Septic shock
|
1.4%
4/278 • Number of events 7 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urinary tract infection
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Urosepsis
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Infections and infestations
Viral infection
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Craniocerebral injury
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Fibula fracture
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Hip fracture
|
0.72%
2/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Overdose
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Injury, poisoning and procedural complications
Tibia fracture
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
1.1%
3/278 • Number of events 4 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
4/251 • Number of events 6 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Neutrophil count decreased
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Platelet count decreased
|
0.72%
2/278 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Adult failure to thrive
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Cachexia
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
1.1%
3/278 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Diabetic metabolic decompensation
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Failure to thrive
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypercalcaemia
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.72%
2/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Lactic acidosis
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
3/251 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Bursitis
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Muscular weakness
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Acute myeloid leukaemia
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
0.36%
1/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebral ischaemia
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Ischaemic stroke
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Lethargy
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Metabolic encephalopathy
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Neuropathy peripheral
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Product Issues
Device breakage
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Product Issues
Device failure
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Product Issues
Device occlusion
|
1.1%
3/278 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Completed suicide
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Mental status changes
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Suicide attempt
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.72%
2/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Cystitis haemorrhagic
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Oliguria
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Renal failure
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Renal and urinary disorders
Urinary tract obstruction
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Reproductive system and breast disorders
Prostatic obstruction
|
0.69%
1/144 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/134 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.72%
2/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
0.72%
2/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.72%
2/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.2%
3/251 • Number of events 3 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory acidosis
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Aortic embolus
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Deep vein thrombosis
|
0.36%
1/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Embolism
|
0.72%
2/278 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.80%
2/251 • Number of events 2 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Internal haemorrhage
|
0.36%
1/278 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Vascular disorders
Peripheral coldness
|
0.00%
0/278 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.40%
1/251 • Number of events 1 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Other adverse events
| Measure |
Pegilodecakin + FOLFOX
n=278 participants at risk
Pegilodecakin 5 μg/kg dosed as one of the following 2 fixed doses: 0.4 mg for participants weighing ≤80 kg or 0.8 mg for participants weighing\>80 kg on Days 1-5 and Days 8-12 subcutaneously (SC) plus FOLFOX \[dl-Leucovorin (dl-LV) 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5-fluorouracil (5-FU) 400 mg/m2 and a 46 to 48 hour infusion of 5- FU 2400 mg/m2\] initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression. After discontinuation of FOLFOX in the absence of tumor progression \[that is (i.e., completion of the planned 12 cycles or unacceptable FOLFOX related toxicity\], Pegilodecakin 10µg/kg maintenance treatment administered as one of the 2 fixed doses, either 0.8 mg for participants weighing ≤80 kg or 1.6 mg for participants weighing\>80 kg.
|
FOLFOX
n=251 participants at risk
FOLFOX (dl-LV 400 mg/m2 and oxaliplatin 85 mg/m2 followed by bolus 5- FU 400 mg/m2 and a 46-hour infusion of 5-FU 2400 mg/m2) initiated on Day 1 of a 14-day cycles for up to 12 cycles or until disease progression.
|
|---|---|---|
|
Nervous system disorders
Paraesthesia
|
8.6%
24/278 • Number of events 34 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.8%
17/251 • Number of events 44 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
11.2%
31/278 • Number of events 48 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.6%
29/251 • Number of events 35 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Polyneuropathy
|
3.2%
9/278 • Number of events 13 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.6%
14/251 • Number of events 25 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Psychiatric disorders
Insomnia
|
5.0%
14/278 • Number of events 14 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.2%
13/251 • Number of events 13 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.1%
17/278 • Number of events 22 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.6%
19/251 • Number of events 22 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
10.8%
30/278 • Number of events 41 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.0%
15/251 • Number of events 17 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
5.4%
15/278 • Number of events 24 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
8/251 • Number of events 11 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Anaemia
|
38.5%
107/278 • Number of events 204 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
15.1%
38/251 • Number of events 56 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Neutropenia
|
20.9%
58/278 • Number of events 118 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
16.3%
41/251 • Number of events 65 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
35.6%
99/278 • Number of events 296 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.2%
28/251 • Number of events 42 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal distension
|
6.5%
18/278 • Number of events 22 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.6%
14/251 • Number of events 15 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain
|
29.5%
82/278 • Number of events 114 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
23.1%
58/251 • Number of events 82 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
7.2%
20/278 • Number of events 34 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.6%
14/251 • Number of events 17 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Ascites
|
10.1%
28/278 • Number of events 35 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
7.6%
19/251 • Number of events 20 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Constipation
|
28.4%
79/278 • Number of events 93 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
23.5%
59/251 • Number of events 70 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Diarrhoea
|
25.2%
70/278 • Number of events 104 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
28.3%
71/251 • Number of events 101 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Dyspepsia
|
7.6%
21/278 • Number of events 23 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.6%
14/251 • Number of events 16 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Flatulence
|
5.0%
14/278 • Number of events 15 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
1.6%
4/251 • Number of events 6 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Nausea
|
45.3%
126/278 • Number of events 217 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
42.2%
106/251 • Number of events 160 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Stomatitis
|
9.7%
27/278 • Number of events 37 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
15.9%
40/251 • Number of events 48 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Gastrointestinal disorders
Vomiting
|
28.8%
80/278 • Number of events 122 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
27.5%
69/251 • Number of events 106 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Asthenia
|
27.3%
76/278 • Number of events 151 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
17.9%
45/251 • Number of events 105 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Fatigue
|
37.8%
105/278 • Number of events 181 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
29.5%
74/251 • Number of events 108 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Skin and subcutaneous tissue disorders
Rash
|
8.3%
23/278 • Number of events 34 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.6%
9/251 • Number of events 10 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Injection site erythema
|
6.5%
18/278 • Number of events 18 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
0.00%
0/251 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Oedema peripheral
|
14.7%
41/278 • Number of events 49 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
8.8%
22/251 • Number of events 25 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
General disorders
Pyrexia
|
20.1%
56/278 • Number of events 82 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
14.3%
36/251 • Number of events 51 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Aspartate aminotransferase increased
|
4.3%
12/278 • Number of events 17 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.6%
14/251 • Number of events 22 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood alkaline phosphatase increased
|
7.6%
21/278 • Number of events 28 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.0%
15/251 • Number of events 20 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Blood bilirubin increased
|
6.8%
19/278 • Number of events 28 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
10/251 • Number of events 12 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Neutrophil count decreased
|
16.9%
47/278 • Number of events 84 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.0%
30/251 • Number of events 51 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Platelet count decreased
|
21.2%
59/278 • Number of events 163 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.4%
26/251 • Number of events 51 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Investigations
Weight decreased
|
5.0%
14/278 • Number of events 17 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
10.0%
25/251 • Number of events 34 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
34.9%
97/278 • Number of events 132 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
30.7%
77/251 • Number of events 100 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Dehydration
|
4.3%
12/278 • Number of events 22 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
5.6%
14/251 • Number of events 19 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
5.0%
14/278 • Number of events 20 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
10/251 • Number of events 11 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypoalbuminaemia
|
7.2%
20/278 • Number of events 28 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
4.0%
10/251 • Number of events 11 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hypokalaemia
|
7.6%
21/278 • Number of events 37 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
11.6%
29/251 • Number of events 39 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
4.0%
11/278 • Number of events 15 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.4%
16/251 • Number of events 21 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
37/278 • Number of events 44 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
12.7%
32/251 • Number of events 39 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dizziness
|
6.8%
19/278 • Number of events 23 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.2%
8/251 • Number of events 9 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Dysgeusia
|
6.8%
19/278 • Number of events 22 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
3.6%
9/251 • Number of events 11 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Headache
|
6.5%
18/278 • Number of events 24 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.8%
17/251 • Number of events 20 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Neuropathy peripheral
|
14.4%
40/278 • Number of events 50 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
15.1%
38/251 • Number of events 62 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
|
Nervous system disorders
Neurotoxicity
|
4.7%
13/278 • Number of events 25 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
6.0%
15/251 • Number of events 30 • Baseline Up To 36 Months
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60