Trial Outcomes & Findings for Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054) (NCT NCT02362594)
NCT ID: NCT02362594
Last Updated: 2025-10-15
Results Overview
RFS was defined as the time between the date of randomization and the date of first melanoma recurrence (local, regional, distant metastasis) or death (whatever the cause), whichever occurred first. For participants who remained alive and whose disease had not recurred, RFS was censored on the date of last visit/contact with disease assessments. The percentage of participants with RFS at Month 6 was reported for all participants in both treatment arms of Part 1.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE3
Target enrollment
1019 participants
Primary outcome timeframe
6 months
Results posted on
2025-10-15
Participant Flow
As of the 02-Oct-2017 interim database cut-off date, of the 1019 randomized participants in Part 1, 544 had completed Part 1 and 62 were continuing in Part 1. This interim results disclosure is for Part 1 only.
Participant milestones
| Measure |
Pembrolizumab
In Part 1, participants received pembrolizumab 200 mg intravenously (IV) as post-surgery therapy every 3 weeks (Q3W) for up to 1 year.
|
Placebo
In Part 1, participants received placebo IV as post-surgery therapy Q3W.
|
|---|---|---|
|
Overall Study
STARTED
|
514
|
505
|
|
Overall Study
Treated
|
509
|
502
|
|
Overall Study
Continuing Part 1 Adjuvant Therapy
|
41
|
21
|
|
Overall Study
COMPLETED
|
264
|
280
|
|
Overall Study
NOT COMPLETED
|
250
|
225
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Pembrolizumab
n=514 Participants
In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
|
Placebo
n=505 Participants
In Part 1, participants received placebo IV as post-surgery therapy Q3W.
|
Total
n=1019 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
53.9 Years
STANDARD_DEVIATION 13.6 • n=514 Participants
|
53.7 Years
STANDARD_DEVIATION 14.2 • n=505 Participants
|
53.8 Years
STANDARD_DEVIATION 13.9 • n=1019 Participants
|
|
Sex: Female, Male
Female
|
190 Participants
n=514 Participants
|
201 Participants
n=505 Participants
|
391 Participants
n=1019 Participants
|
|
Sex: Female, Male
Male
|
324 Participants
n=514 Participants
|
304 Participants
n=505 Participants
|
628 Participants
n=1019 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Programmed Death-Ligand 1 (PD-L1) Tumor Status
PD-L1 Positive
|
428 Participants
n=514 Participants
|
425 Participants
n=505 Participants
|
853 Participants
n=1019 Participants
|
|
Programmed Death-Ligand 1 (PD-L1) Tumor Status
PD-L1 Negative
|
59 Participants
n=514 Participants
|
57 Participants
n=505 Participants
|
116 Participants
n=1019 Participants
|
|
Programmed Death-Ligand 1 (PD-L1) Tumor Status
Undetermined
|
27 Participants
n=514 Participants
|
23 Participants
n=505 Participants
|
50 Participants
n=1019 Participants
|
|
Melanoma Stage
Stage IIIA (> 1 mm)
|
80 Participants
n=514 Participants
|
80 Participants
n=505 Participants
|
160 Participants
n=1019 Participants
|
|
Melanoma Stage
Stage IIIB
|
237 Participants
n=514 Participants
|
230 Participants
n=505 Participants
|
467 Participants
n=1019 Participants
|
|
Melanoma Stage
Stage IIIC (1-3 LN+)
|
95 Participants
n=514 Participants
|
93 Participants
n=505 Participants
|
188 Participants
n=1019 Participants
|
|
Melanoma Stage
Stage IIIC (≥4 LN+)
|
102 Participants
n=514 Participants
|
102 Participants
n=505 Participants
|
204 Participants
n=1019 Participants
|
|
Region of Enrollment
North America
|
38 Participants
n=514 Participants
|
37 Participants
n=505 Participants
|
75 Participants
n=1019 Participants
|
|
Region of Enrollment
Europe
|
341 Participants
n=514 Participants
|
336 Participants
n=505 Participants
|
677 Participants
n=1019 Participants
|
|
Region of Enrollment
Australia/New Zealand
|
111 Participants
n=514 Participants
|
112 Participants
n=505 Participants
|
223 Participants
n=1019 Participants
|
|
Region of Enrollment
Other
|
24 Participants
n=514 Participants
|
20 Participants
n=505 Participants
|
44 Participants
n=1019 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All randomized participants in Part 1.
RFS was defined as the time between the date of randomization and the date of first melanoma recurrence (local, regional, distant metastasis) or death (whatever the cause), whichever occurred first. For participants who remained alive and whose disease had not recurred, RFS was censored on the date of last visit/contact with disease assessments. The percentage of participants with RFS at Month 6 was reported for all participants in both treatment arms of Part 1.
Outcome measures
| Measure |
Pembrolizumab
n=514 Participants
In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
|
Placebo
n=505 Participants
In Part 1, participants received placebo IV as post-surgery therapy Q3W.
|
|---|---|---|
|
Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among All Participants
|
82.2 Percentage of Participants
Interval 78.6 to 85.3
|
73.3 Percentage of Participants
Interval 69.2 to 77.0
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: All randomized participants in Part 1 with PD-L1-positive tumors.
RFS was defined as the time between the date of randomization and the date of first melanoma recurrence (local, regional, distant metastasis) or death (whatever the cause), whichever occurred first. For participants who remained alive and whose disease had not recurred, RFS was censored on the date of last visit/contact with disease assessments. The percentage of participants with RFS at Month 6 was reported for all participants with PD-L1-positive tumors in both treatment arms of Part 1.
Outcome measures
| Measure |
Pembrolizumab
n=428 Participants
In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
|
Placebo
n=425 Participants
In Part 1, participants received placebo IV as post-surgery therapy Q3W.
|
|---|---|---|
|
Part 1: Percentage of Participants With Recurrence-Free Survival (RFS) At 6 Months Among Participants With PD-L1-positive Tumor Expression
|
83.8 Percentage of Participants
Interval 80.0 to 87.0
|
75.4 Percentage of Participants
Interval 71.0 to 79.2
|
SECONDARY outcome
Timeframe: Up to approximately 11 yearsDMFS will be defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. For participants who remain alive and distant metastasis-free, DMFS will be censored on the date of last visit/contact with disease assessments. The percentage of participants with DMFS will be reported for all participants in both treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 11 yearsDescription: DMFS will be defined as the time between the date of randomization and the date of first distant metastasis or date of death (whatever the cause), whichever occurs first. For participants who remain alive and distant metastasis-free, DMFS will be censored on the date of last visit/contact with disease assessments. The percentage of participants with DMFS will be reported for all participants with PD-L1-positive tumors in both treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 11 yearsOS will be defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of participants still alive will be censored at the moment of last visit/contact. OS will be reported for all participants in both treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to approximately 11 yearsOS will be defined as the time from the date of randomization to the date of death, whatever the cause. The follow-up of participants still alive will be censored at the moment of last visit/contact. OS will be reported for all participants with PD-L1-positive tumors in both treatment arms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 22 monthsPopulation: All randomized participants in Part 1 who received at least 1 dose of study treatment.
An AE is defined as "any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment". An AE can therefore be any unfavorable and unintended signs (such as rash or enlarged liver), symptoms (such as nausea or chest pain), an abnormal laboratory finding (including results of blood tests, x-rays or scans) or a disease temporarily associated with the use of the protocol treatment, whether or not considered related to the investigational medicinal product. The number of participants who experienced at least 1 AE was reported for all participants in each treatment arm.
Outcome measures
| Measure |
Pembrolizumab
n=509 Participants
In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
|
Placebo
n=502 Participants
In Part 1, participants received placebo IV as post-surgery therapy Q3W.
|
|---|---|---|
|
Number of Participants Who Experienced At Least 1 Adverse Event (AE)
|
475 Participants
|
453 Participants
|
SECONDARY outcome
Timeframe: Up to 22 monthsPopulation: All randomized participants in Part 1 who received at least 1 dose of study treatment.
An AE is defined as "any untoward medical occurrence in a participant which does not necessarily have to have a causal relationship with this treatment". An AE can therefore be any unfavorable and unintended signs (such as rash or enlarged liver), symptoms (such as nausea or chest pain), an abnormal laboratory finding (including results of blood tests, x-rays or scans) or a disease temporarily associated with the use of the protocol treatment, whether or not considered related to the investigational medicinal product. The number of participants who discontinued study treatment due to an AE was reported for all participants in each treatment arm.
Outcome measures
| Measure |
Pembrolizumab
n=509 Participants
In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
|
Placebo
n=502 Participants
In Part 1, participants received placebo IV as post-surgery therapy Q3W.
|
|---|---|---|
|
Number of Participants Who Discontinued Study Treatment Due to an Adverse Event (AE)
|
70 Participants
|
18 Participants
|
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and then Day 1 of cycle for every 4 cycles afterwards (up to approximately 16 months). Each cycle is 3 weeks.Population: As pre-specified by the protocol, pembrolizumab CL was not analyzed as planned and no data were collected since by the time of the interim analysis, pembrolizumab pharmacokinetics (PK) in melanoma patients had been well characterized and found to be consistent with the overall clinical pharmacology of pembrolizumab characterized across indications.
Blood samples were to be collected at pre-specified time points and plasma isolated for analysis of pembrolizumab CL, defined as the volume of plasma from which pembrolizumab is eliminated per unit time following IV pembrolizumab administration. Samples were not collected and this analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and then Day 1 of cycle for every 4 cycles afterwards (up to approximately 16 months). Each cycle is 3 weeks.Population: As pre-specified by the protocol, pembrolizumab V was not analyzed as planned and no data were collected since by the time of the interim analysis, pembrolizumab PK in melanoma patients had been well characterized and found to be consistent with the overall clinical pharmacology of pembrolizumab characterized across indications.
Blood samples were to be collected at pre-specified time points and plasma isolated for analysis of pembrolizumab V, defined as the theoretical volume that would be necessary to contain the total amount of administered pembrolizumab at the same concentration that it is observed in the blood plasma. Samples were not collected and this analysis was not performed.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Pre-dose on Day 1 of Cycles 1, 2, 4, 6, and 8, and then Day 1 of cycle for every 4 cycles afterwards (up to approximately 16 months). Each cycle is 3 weeks.Population: All randomized participants in Part 1 who had at least one ADA sample available after treatment with pembrolizumab and who had treatment emergent positive, non-treatment emergent positive, or negative immunogenicity status. Participants receiving Placebo treatment in Part 1 were not analyzed for ADA.
Pre- and post-baseline serum samples from participants treated with pembrolizumab were analyzed for ADA by means of a neutralizing antibody assay which assessed the ability of ADA to block (neutralize) binding of pembrolizumab to Programmed Cell Death-1 (PD-1) protein. Overall immunogenicity was defined as the number of treatment emergent positive participants based on the total number of evaluable participants (treatment emergent positive, non-treatment emergent positive and negative immunogenicity status).
Outcome measures
| Measure |
Pembrolizumab
n=495 Participants
In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
|
Placebo
In Part 1, participants received placebo IV as post-surgery therapy Q3W.
|
|---|---|---|
|
Number of Participants Positive for Anti-Drug Antibodies (ADA) After Pembrolizumab Treatment
Negative
|
473 Participants
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies (ADA) After Pembrolizumab Treatment
Non-Treatment emergent positive
|
5 Participants
|
—
|
|
Number of Participants Positive for Anti-Drug Antibodies (ADA) After Pembrolizumab Treatment
Treatment emergent positive
|
17 Participants
|
—
|
Adverse Events
Pembrolizumab
Serious events: 128 serious events
Other events: 443 other events
Deaths: 25 deaths
Placebo
Serious events: 82 serious events
Other events: 409 other events
Deaths: 35 deaths
Serious adverse events
| Measure |
Pembrolizumab
n=509 participants at risk
In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
|
Placebo
n=502 participants at risk
In Part 1, participants received placebo IV as post-surgery therapy Q3W.
|
|---|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Autoimmune pericarditis
|
0.20%
1/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Cardiac failure congestive
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Myocarditis
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Cardiac disorders
Ventricular tachycardia
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Adrenocortical insufficiency acute
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hyperthyroidism
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypophysitis
|
0.59%
3/509 • Number of events 3 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypopituitarism
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Secondary adrenocortical insufficiency
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Thyroiditis
|
0.39%
2/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Eye disorders
Conjunctivitis allergic
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Aptyalism
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Autoimmune colitis
|
0.59%
3/509 • Number of events 6 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Colitis
|
1.6%
8/509 • Number of events 11 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.98%
5/509 • Number of events 9 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
2/502 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Enteritis
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Food poisoning
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Gastritis
|
0.39%
2/509 • Number of events 3 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 3 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Ileus
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Large intestine perforation
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Oesophageal haemorrhage
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Oral lichen planus
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatitis
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Pancreatitis acute
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Small intestinal perforation
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Discomfort
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Fatigue
|
0.39%
2/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Granuloma
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Oedema
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Papillitis
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Pyrexia
|
0.79%
4/509 • Number of events 8 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Systemic inflammatory response syndrome
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Autoimmune hepatitis
|
0.39%
2/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Hepatobiliary disorders
Hepatitis
|
0.39%
2/509 • Number of events 8 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Immune system disorders
Anaphylactic reaction
|
0.39%
2/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Immune system disorders
Sarcoidosis
|
0.39%
2/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Bronchitis
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Cellulitis
|
0.59%
3/509 • Number of events 4 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.4%
7/502 • Number of events 8 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Cholecystitis infective
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Erysipelas
|
0.39%
2/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.80%
4/502 • Number of events 4 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Gastroenteritis viral
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Infected seroma
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
2/502 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Infection
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Lung infection
|
0.20%
1/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Pneumonia
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Post procedural cellulitis
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Skin infection
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Soft tissue infection
|
0.20%
1/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Subcutaneous abscess
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Viral infection
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Vulvitis
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Post procedural haematoma
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Spinal column injury
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Subarachnoid haemorrhage
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Synovial rupture
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Injury, poisoning and procedural complications
Wound necrosis
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
0.39%
2/509 • Number of events 3 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Aspartate aminotransferase increased
|
0.59%
3/509 • Number of events 4 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Gamma-glutamyltransferase increased
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.39%
2/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
0.39%
2/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hypercreatininaemia
|
0.20%
1/509 • Number of events 4 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.39%
2/509 • Number of events 5 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.20%
1/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
2/502 • Number of events 3 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Type 1 diabetes mellitus
|
0.59%
3/509 • Number of events 5 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Fasciitis
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.20%
1/509 • Number of events 3 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.40%
2/502 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myositis
|
0.20%
1/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Rheumatoid arthritis
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenoma benign
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Angiolipoma
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
3.3%
17/509 • Number of events 24 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
25/502 • Number of events 36 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign lymph node neoplasm
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Benign neoplasm of testis
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Bowen's disease
|
0.79%
4/509 • Number of events 4 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Choroid melanoma
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Hepatocellular carcinoma
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Intracranial tumour haemorrhage
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Keratoacanthoma
|
0.20%
1/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Leydig cell tumour of the testis
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma
|
0.59%
3/509 • Number of events 3 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.60%
3/502 • Number of events 4 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant melanoma in situ
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
6/502 • Number of events 6 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Mantle cell lymphoma
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Meningioma
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to central nervous system
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Nodular melanoma
|
0.20%
1/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectal adenocarcinoma
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Renal cell carcinoma
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma
|
1.2%
6/509 • Number of events 10 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.60%
3/502 • Number of events 4 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Superficial spreading melanoma stage unspecified
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Thyroid cancer
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Carotid artery aneurysm
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Cerebrovascular accident
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Facial paralysis
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Headache
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Myasthenia gravis
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.20%
1/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Sciatica
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Psychiatric disorders
Anxiety
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Acute kidney injury
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Autoimmune nephritis
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Glomerulosclerosis
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Nephritis
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 4 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.20%
1/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Renal colic
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Tubulointerstitial nephritis
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Renal and urinary disorders
Urinary retention
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
1.4%
7/509 • Number of events 8 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.39%
2/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Drug reaction with eosinophilia and systemic symptoms
|
0.20%
1/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Lichenoid keratosis
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.20%
1/509 • Number of events 3 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.20%
1/509 • Number of events 2 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Surgical and medical procedures
Appendicectomy
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Deep vein thrombosis
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Haematoma
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Hypotension
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Lymphoedema
|
0.20%
1/509 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.00%
0/502 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Venous thrombosis
|
0.00%
0/509 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
0.20%
1/502 • Number of events 1 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
Other adverse events
| Measure |
Pembrolizumab
n=509 participants at risk
In Part 1, participants received pembrolizumab 200 mg IV as post-surgery therapy Q3W for up to 1 year.
|
Placebo
n=502 participants at risk
In Part 1, participants received placebo IV as post-surgery therapy Q3W.
|
|---|---|---|
|
Endocrine disorders
Hyperthyroidism
|
10.2%
52/509 • Number of events 61 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
1.2%
6/502 • Number of events 6 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Endocrine disorders
Hypothyroidism
|
14.7%
75/509 • Number of events 93 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.8%
14/502 • Number of events 14 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Abdominal pain
|
7.3%
37/509 • Number of events 40 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.2%
31/502 • Number of events 37 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Constipation
|
6.7%
34/509 • Number of events 37 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.8%
29/502 • Number of events 32 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Diarrhoea
|
27.5%
140/509 • Number of events 238 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
25.7%
129/502 • Number of events 234 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Dry mouth
|
5.9%
30/509 • Number of events 32 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.0%
10/502 • Number of events 10 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Nausea
|
17.3%
88/509 • Number of events 112 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
14.5%
73/502 • Number of events 103 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Gastrointestinal disorders
Vomiting
|
7.9%
40/509 • Number of events 55 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.4%
22/502 • Number of events 25 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Asthenia
|
11.0%
56/509 • Number of events 93 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.4%
42/502 • Number of events 71 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Fatigue
|
33.0%
168/509 • Number of events 247 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
33.5%
168/502 • Number of events 232 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
General disorders
Influenza like illness
|
10.8%
55/509 • Number of events 73 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.6%
38/502 • Number of events 47 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Nasopharyngitis
|
8.6%
44/509 • Number of events 54 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
25/502 • Number of events 26 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Infections and infestations
Upper respiratory tract infection
|
7.7%
39/509 • Number of events 49 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.0%
30/502 • Number of events 39 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Alanine aminotransferase increased
|
6.9%
35/509 • Number of events 41 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.8%
24/502 • Number of events 30 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Weight decreased
|
10.8%
55/509 • Number of events 69 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
7.8%
39/502 • Number of events 64 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Investigations
Weight increased
|
12.4%
63/509 • Number of events 96 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
16.3%
82/502 • Number of events 117 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
7.1%
36/509 • Number of events 40 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
2.6%
13/502 • Number of events 15 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
15.5%
79/509 • Number of events 130 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
14.3%
72/502 • Number of events 98 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
6.7%
34/509 • Number of events 37 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
10.8%
54/502 • Number of events 69 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
6.9%
35/509 • Number of events 40 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
25/502 • Number of events 29 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.3%
22/509 • Number of events 26 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.0%
30/502 • Number of events 34 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Dizziness
|
5.1%
26/509 • Number of events 29 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
6.2%
31/502 • Number of events 38 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Nervous system disorders
Headache
|
18.7%
95/509 • Number of events 135 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
18.5%
93/502 • Number of events 126 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.8%
70/509 • Number of events 88 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.0%
55/502 • Number of events 66 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
9.0%
46/509 • Number of events 50 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
5.0%
25/502 • Number of events 26 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
19.4%
99/509 • Number of events 138 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
11.6%
58/502 • Number of events 74 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash
|
13.2%
67/509 • Number of events 90 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
8.6%
43/502 • Number of events 51 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
5.3%
27/509 • Number of events 44 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
4.8%
24/502 • Number of events 26 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
|
Vascular disorders
Hypertension
|
14.5%
74/509 • Number of events 178 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
15.3%
77/502 • Number of events 209 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
|
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Vascular disorders
Lymphoedema
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5.1%
26/509 • Number of events 28 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
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7.2%
36/502 • Number of events 37 • Up to 29 months (through database cut-off date of 02-Oct-2017)
All-Cause Mortality was reported for all randomized participants in Part 1. Serious AEs and Other AEs were reported for all randomized participants who received at least 1 dose of study treatment in Part 1. Per protocol, disease progression of cancer on study was not considered an AE unless considered related to study drug. Therefore, MedDRA preferred terms "Neoplasm progression", "Malignant neoplasm progression" and "Disease progression" not related to study drug are excluded as AEs.
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Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme LLC
Phone: 1-800-672-6372
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee All draft publications, including abstracts or detailed summaries of any proposed presentations, must be submitted to the Sponsor at the earliest practicable time for review, not less than 30 days before submission or presentation unless otherwise set forth in the clinical trial agreement. Sponsor shall have the right to delete any confidential information contained in any proposed presentation or abstract and may delay publication for up to 60 days for purposes of filing a patent application.
- Publication restrictions are in place
Restriction type: OTHER